Methods and systems for qualifying physiological values based on metrics

ABSTRACT

A physiological monitoring system may process a physiological signal such a photoplethysmograph signal from a subject. The system may determine physiological information, such as a physiological rate, from the physiological signal. The system may use search techniques and qualification techniques to determine one or more initialization parameters. The initialization parameters may be used to calculate and qualify a physiological rate. The system may use signal conditioning to reduce noise in the physiological signal and to improve the determination of physiological information. The system may use qualification techniques to confirm determined physiological parameters. The system may also use autocorrelation techniques, cross-correlation techniques, fast start techniques, and/or reference waveforms when processing the physiological signal.

The present disclosure relates to determining physiological information.More particularly, the present disclosure relates to qualifying a valueindicative of a physiological rate based on two metrics.

SUMMARY

A physiological monitor may determine one or more physiologicalparameters such as, for example, a physiological rate based on signalsreceived from one or more physiological sensors. The physiologicalmonitor may analyze physiological signals (e.g., photoplethysmographic(PPG) signals) for oscillometric behavior characterized by a pulse rate,a respiration rate, or both. Physiological signals may include one ormore noise components, which may include the effects of ambient light,electromagnetic radiation from powered devices (e.g., at 60 Hz or 50HZ), subject movement, and/or other non-physiological or undesiredphysiological signal components. In some circumstances, thedetermination of a pulse rate from photoplethysmographic information maypresent challenges. Factors such as, for example, noise, subjectmovement, the shape of physiological pulses, subjects having lowperfusion with small physiological pulses, and/or other factors maypresent challenges in determining pulse rate.

The physiological monitor in accordance with the present disclosure mayinclude a sensor, having a detector, which may generate an intensitysignal (e.g., a PPG signal) based on light attenuated by the subject.Processing equipment of the monitor, a processing module, and/or othersuitable processing equipment may determine a value indicative of aphysiological rate based on the intensity signal. For example, theprocessing equipment may determine a pulse rate based on analysis of theintensity signal.

In some embodiments, the processing equipment may use a search mode anda locked mode to determine a physiological parameter of a subject. Thesearch mode may be used to determine one or more initializationparameters and the locked mode may use the one or more initializationparameters to determine the physiological parameter (e.g., pulse rate)of the subject. The locked mode may use, for example, a relativelynarrow band-pass filter that is initially tuned based on the one or moreinitialization parameters and is subsequently tuned based on previouslydetermined physiological parameters. A relatively narrow, adjustableband-pass filter is good at rejecting noise when it is tuned to thecorrect rate. The search and locked modes may include qualificationtechniques to qualify the one or more initialization parameters and thephysiological parameters. The qualification techniques can prevent theband-pass filter from being initially tuned to noise and can prevent theband-pass filter from deviating away from the correct physiologicalrate. In addition, in the event that the band-pass is tuned incorrectly,the processing equipment may determine to return to the search modebased on qualification failure information to reset the one or moreinitialization parameters. Accordingly, physiological parameters (e.g.,pulse rate) may be reliably determined in the presence of noise.

In some embodiments, the processing equipment may determine one or moreinitialization parameters (e.g., an algorithm setting) based on theintensity signal, and determine a value indicative of a physiologicalrate of the subject based on the intensity signal and based on thealgorithm setting. Determining the value indicative of the physiologicalrate may include performing a correlation calculation such as anautocorrelation, and/or filtering a signal based on the algorithmsetting, wherein the signal is based on the intensity signal. Thefiltering may include applying a bandpass filter based on the algorithmsettings. In some embodiments, the processing equipment may generate athreshold based on the correlation signal and/or algorithm setting, andidentify threshold crossings. For example, the processing equipment maydetermine a difference (e.g., a time interval or number of samples)associated with at least two threshold crossings, and then determine thevalue indicative of the physiological rate based on the difference.

In some embodiments, the processing equipment may calculate anautocorrelation sequence based on the intensity signal, and identify anumber of times the autocorrelation sequence crosses a threshold at eachof a plurality of threshold settings. In some embodiments, the number ofcrossings may be converted to a value indicative of a physiological ratebased on the length of the autocorrelation sequence. In someembodiments, the intensity signal may be conditioned using, for example,a detrending calculation. The autocorrelation sequence may be generatedby selecting a first and a second portion of the conditioned intensitysignal and performing a correlation calculation at a plurality ofdifferent lags. Analysis of the stability of the number of thresholdcrossings over two or more of the plurality of threshold settings mayaid the processing equipment in determining the value indicative of aphysiological rate. For example, the processing equipment may analyzethe stability by determining and/or selecting a stable region where thenumber of threshold crossing remains substantially the same for a rangeof threshold values. In some embodiments, the processing equipment mayidentify one or more peaks of the autocorrelation sequence, anddetermine the value indicative of a physiological rate of the subjectbased on an analysis of the shape of the one or more peaks. The shapeanalysis may be based on a symmetry of the one or more peaks, a width ofthe one or more peaks, an amplitude of the one or more peaks, or othershape information. In some embodiments, the analysis may includeidentifying a plurality of peaks of the autocorrelation sequence,disqualifying peaks that do not meet one or more criteria, and thendetermining the value indicative of the physiological rate based on oneor more of the non-disqualified peaks. In some embodiments, the numberof crossing may be converted to one or more initialization settings(e.g., an algorithm setting).

In some embodiments, the processing equipment may perform a firstmodulation on an intensity signal to generate a first modulatedintensity signal using a first modulation signal, and a secondmodulation on an intensity signal to generate a second modulatedintensity signal using a second modulation signal. The first and secondmodulation signals may be sinusoids relatively shifted in phase such as,for example, a sine signal and a cosine signal. In some embodiments, themodulated signals may be low-pass filtered. Analysis of a phase signalbased on the first modulated intensity signal and the second modulatedintensity signal may aid in determining a value indicative of aphysiological rate of the subject based on the phase signal. In someembodiments, a plurality of first modulated intensity signals and secondmodulated intensity signals may be generated over a range of modulationfrequencies. The analysis may include analyzing phase signals based onthe plurality of first modulated intensity signals and the plurality ofsecond modulated intensity signals, and the value indicative of thephysiological rate may be determined based on the phase differences. Forexample, a modulation frequency that provides a substantially stablephase difference may be used to determine the value indicative of aphysiological rate. In some embodiments, the analysis of one or morephase signals may aid in determining one or more initialization settings(e.g., an algorithm setting).

In some embodiments, the processing equipment may calculate anautocorrelation sequence based on the intensity signal, which may beconditioned, and then calculate a cross-correlation sequence of theautocorrelation sequence and a cross-correlation waveform to determine avalue indicative of a physiological rate of the subject. In someembodiments, the conditioning may include generating a signal to fit asegment of the intensity signal such as a line fit, a quadratic curvefit, or a cubic curve fit, and then modifying the intensity signal bysubtracting the generated signal. In some embodiments, an absolute valueof the cross-correlation sequence may be used for analysis. The analysismay be based on a peak in the calculated absolute values. In someembodiments, a cross-correlation waveform having a plurality of segmentshaving different frequency components may be used. For example, theplurality of segments may include one or more base waveforms, having adifferent associated frequency, for each of the plurality of segments.In a further example, one or more base waveforms for a particularsegment may be a temporal-scaled and/or amplitude-scaled version of oneor more base waveforms for another one of the plurality of segments. Oneor more of the plurality of segments may include temporal dithering ofassociated base waveform(s). In some embodiments, a secondcross-correlation may be calculated, having segments each with differentcharacteristics, and different from the first cross-correlationwaveform. Accordingly, the one or both of the cross-correlations may beused to determine the value indicative of the physiological rate. Insome embodiments, a peak based on the cross-correlation sequence may beidentified and analyzed. In some embodiments, an envelope based on thecross-correlation sequence may be generated, and the peak may beidentified from the envelope. In some embodiments, values in thecross-correlation sequence that correspond to each of the plurality ofsegments may be summed, and the peak may be identified based on thesums. Peaks may be compared to a threshold, which may be determinedbased on the cross-correlation sequence, and/or compared to the nextlargest identified peak. In some embodiments, the cross-correlationsequence may be used to determine one or more initialization settings(e.g., an algorithm setting).

In some embodiments, a first autocorrelation sequence and a secondautocorrelation sequence may be calculated, and then combined todetermine one or more initialization settings (e.g., an algorithmsetting) or a value indicative of physiological information of thesubject. The first and second autocorrelation sequences may becalculated using templates, which may be portions of data, havingdifferent sizes, or the same size. In some embodiments, the first andsecond autocorrelation sequences may be averaged and/or bandpassfiltered. One or more peaks in the combined autocorrelation sequence maybe identified. For example, the difference (e.g., in time or samplenumber) between two peaks may be used to determine the initializationsettings or the value indicative of the physiological rate.

In some embodiments, after determining a value indicative of aphysiological rate of the subject, the processing equipment maydetermine whether to qualify or disqualify the value. Across-correlation sequence based on the intensity signal and a referencewaveform may be calculated. The reference waveform may be based on thevalue indicative of the physiological rate of the subject, and mayoptionally include a pulse shape. A metric indicative of a symmetryassociated with the cross-correlation sequence may be determined and thequalification may be based on the metric. The metric may be based onsymmetry between two segments, which may be, for example, adjacentsegments centered on a peak or valley of the cross-correlation sequence,or segments that may begin at points in the cross-correlation sequencethat are spaced apart from each other and are at approximately equalamplitudes. The value indicative of the physiological rate may befiltering based on the qualification. In some embodiments, two segmentsfrom the cross-correlation sequence may be selected that areapproximately the same size, each having starting points offset by acertain amount (e.g., quarter of a period). The period may be associatedwith the value indicative of the physiological rate, and the segmentsizes may be smaller than, equal to, or larger than the period. In someembodiments, the processing equipment may calculate a sequence ofdifferences, where each is based on a value from a first of the twosegments and a value from a second of the two segments. Thequalification of the value indicative of the physiological rate may bebased on a maximum and a minimum of the calculated differences. In someembodiments, the processing equipment may calculate angles, where eachis based on a value from a first of the two segments and a value from asecond of the two segments. The qualification may be based on a sum ofthe angles. In some embodiments, the foregoing techniques may be used toqualify or disqualify one or more initialization settings.

In some embodiments, qualification may include selecting two signalsegments having different lengths based on the intensity signal. A firstof the two different lengths may be approximately double a second of thetwo different lengths, and be approximately equal to, or twice, a periodassociated with the value indicative of the physiological rate. In someembodiments, a positive area and a negative area for each of the twosignal segments may be calculated, and the difference between the areasmay be calculated. A threshold may be generated based on the difference,and a value based on the difference for a second of the two signalsegments may be compared to the threshold. In some embodiments, a firstmetric may be determined based on the intensity signal. After performinga filtering calculation based on the intensity signal to generate afiltered intensity signal, a second metric based on the filteredintensity signal may be determined. The filtering may include applying ahigh-pass filter having a cutoff of about double the value indicative ofthe physiological rate. The first and second metrics may each includeone of a standard deviation, root-mean-square deviation, an amplitude, asum, and an integral. Qualification may be based on a comparison of thefirst and second metrics. For example, a ratio of the first metric tothe second metric may be determined and compared to a threshold, andqualification may be based on the comparison. In some embodiments,qualification may include selecting two signal segments, which may beadjacent, of approximately equal length based on the intensity signal.An area for each of the two segments may be determined and compared todetermine whether to qualify the value indicative of the physiologicalrate. In some embodiments, a cross-correlation sequence based on theintensity signal and a cross-correlation waveform may be calculated, andthe two signal segments may be selected from the cross-correlationsequence. In some embodiments, the foregoing qualification techniquesmay be used to qualify or disqualify one or more initializationsettings.

In some embodiments, qualification may include analyzing selectedpositive and negative values based on a mean-subtracted intensitysignal. Statistical properties of the positive and negative values maybe calculated, and compared to determine whether to qualify the valueindicative of the physiological rate. In some embodiments, across-correlation sequence based on the intensity signal and across-correlation waveform may be calculated, and the two signalsegments may be selected from the cross-correlation sequence. In someembodiments, the foregoing qualification techniques may be used toqualify or disqualify one or more initialization settings.

In some embodiments, qualification may include calculating a firstcross-correlation sequence based on the intensity signal and a firstreference waveform, and a second cross-correlation sequence based on theintensity signal and a second reference waveform. The first and secondreference waveforms may optionally have different lengths, pulse shapes,or other properties. In some embodiments, a first qualification metricand a second qualification metric may be determined based on the firstcross-correlation sequence and second cross-correlation sequence,respectively, and the metrics may be used to determine whether toqualify the value indicative of the physiological rate. In someembodiments, the foregoing qualification techniques may be used toqualify or disqualify one or more initialization settings.

In some embodiments, when the value indicative of the physiological rateis disqualified, qualification failure information may be analyzed, anda second calculation technique (e.g., which may be different than thefirst technique) may be used to determine a subsequent value indicativeof the physiological rate of the subject. In some embodiments, at leastone qualification metric based on the physiological rate and theintensity signal may be determined. When the value is disqualified, thecorresponding at least one qualification metric may be indicative of theactual physiological rate of the subject, and the selected secondcalculation technique may be configured such that it is more likely toidentify the actual physiological rate of the subject than the firstcalculation technique. In some embodiments, the qualification failureinformation may include a plurality of disqualified values andcorresponding qualification metrics. In some embodiments, the analysismay include identifying a pattern based on historical qualificationinformation. The second calculation technique may optionally include alow pass, high pass, and/or notch filtering calculation based on theintensity signal that is not included in the first calculationtechnique. In some embodiments, when the value indicative of thephysiological rate is disqualified, qualification failure informationmay be analyzed, and a different value indicative of the physiologicalrate may be used for subsequent processing. In some embodiments, atleast one qualification metric may be determined based on the valueindicative of the physiological rate and the intensity signal, and maybe indicative of the actual physiological rate of the subject.Accordingly, the different value may correspond to the actualphysiological rate. In some embodiments, the analysis may determine thatthe value indicative of the physiological rate is indicative of aharmonic of the physiological rate and that the different valuecorresponds to a fundamental frequency of the physiological rate. Insome embodiments, subsequent processing may include performing afiltering calculation based on the intensity signal, in which thefiltering coefficients used in the filtering calculation may be based onthe different value. In some embodiments, subsequent processing mayinclude using a second calculation technique based on the intensitysignal and the different value to determine a second value indicative ofthe physiological rate. In some embodiments, the foregoing techniquesmay be used to improve the determination of one or more initializationsettings.

In some embodiments, a first initialization setting may be determinedbased on an intensity signal using a first calculation technique, and asecond initialization setting may be determined based on the intensitysignal using a second calculation technique. The processing equipmentmay determine whether to qualify each of the first initializationsetting and the second initialization setting. A resultinginitialization setting may be determined based on whether the first andsecond initialization settings are qualified, and the resultinginitialization setting may be used to determine a value indicative of aphysiological rate of the subject. The resulting initialization settingmay be the first initialization setting when the first initializationsetting is qualified and the second initialization is disqualified, orthe resulting initialization setting may be a combination of the firstinitialization setting and the second initialization setting when bothare qualified. The initialization settings may be an algorithm settingand may include a filter configuration, and/or one or more settings usedin generating a threshold.

In some embodiments, an envelope may be generated based on a segment ofthe intensity signal, and the intensity signal may be modified based onthe envelope. The envelope may include an upper envelope and a lowerenvelope, in which the upper envelope includes values greater than thelower envelope, and the upper and lower envelopes do not cross. In someembodiments, the upper envelope may include at least one point of theintensity signal and the lower envelope may include at least one pointof the intensity signal. The modification may include subtracting thelower envelope from a segment of the intensity signal to generate afirst signal, scaling the first signal based on a difference between theupper envelope and the lower envelope to generate a second signal, andsubtracting the mean of the second signal from the second signal togenerate the modified intensity signal. The first signal may be scaledto vary in amplitude between one and negative one, or zero and one, orother suitable range. In some embodiments, generating the envelope mayinclude fitting a function to the intensity signal. In some embodiments,a signal may be generated to fit a segment of the intensity signal, andthe intensity signal may be modified by subtracting the generatedsignal. The generated signal may include a linear signal, a quadraticsignal, and/or a polynomial signal having an order of three or more. Insome embodiments, outlier points in the segment and/or points at eachend of the segment may be downweighted in the fitting process. Anautocorrelation sequence may be calculated based on the modifiedintensity signal, and used to determine one or more initializationparameters or a value indicative of a physiological rate of the subject.A threshold may be generated based on the autocorrelation sequence, andthreshold crossings may be identified. The value indicative of aphysiological rate may be determined based on a difference (e.g., intime or sample number) associated with at least two threshold crossings.

In some embodiments, a value indicative of a physiological rate of thesubject may be determined by calculating an autocorrelation sequencebased on the intensity signal, determining a threshold window having acenter portion not used in the determination of a threshold, determininga threshold at each of a plurality of points of the autocorrelationsequence based on the threshold window to generate a threshold sequence,and determining two or more crossings of the autocorrelation sequenceand the threshold sequence. The threshold window may include a centerportion including a sample under test and at least two guard samplesadjacent to the sample under test located on each side of the sampleunder test. The threshold window may also include at least two basesamples located outside of the center portion located on each side ofthe center portion. In some embodiments, the number of guard samplesand/or base samples may be based on an initialization parameter or apreviously determined value indicative of the physiological rate. Thetwo or more crossings may include a least one pair of crossings thatcorrespond to a peak in the autocorrelation sequence, where the peakintersects the threshold sequence at the pair crossings. In someembodiments, a binary signal may be generated based on the thresholdcrossings.

In some embodiments, a correlation sequence may be calculated based on aportion of the intensity signal and a stored reference waveform, andphysiological rate information may be determined based on thecorrelation sequence. A new reference waveform that is derived from theintensity signal may be selected based on the physiological rateinformation and/or based on a period associated with the rateinformation. The new reference waveform may be qualified, stored, andused for calculating a subsequent correlation sequence based on a morerecent portion of the intensity signal and the new reference waveform.Determination of whether to qualify the new reference waveform may bebased on shape analysis of the new reference waveform. Subsequentphysiological rate information may be determined based on the subsequentcorrelation sequence. If the new reference waveform is not qualified,the new reference waveform may be discarded, and a subsequentcorrelation sequence may be calculated based on a more recent portion ofthe intensity signal and a previously stored reference waveform. In someembodiments, physiological rate information may be determined bygenerating a threshold based on the correlation sequence, identifyingthreshold crossings, and determining a difference (e.g., in time orsample number) associated with at least two threshold crossings.

In some embodiments, an intensity signal may be classified based on oneor more classifications such as a dicrotic notch classification, aneonate classification, and/or any other suitable classification. Acalculation technique for determining an initialization parameter or avalue indicative of a physiological rate may be selected from aplurality of calculation techniques based on the classification. Forexample, the selected calculation technique may include a high passfilter when the classification of the intensity signal is a neonateclassification. In a further example, the selected calculation techniquemay include stricter qualification criteria when the classification ofthe intensity signal is a dicrotic notch classification. In someembodiments, the selected calculation technique may be configured todetermine when an initialization parameter or a calculated valuecorresponds to a harmonic of the physiological rate and/or modify theinitialization parameter or calculated value to correspond to thephysiological rate when the classification of the intensity signal is adicrotic notch classification.

In some embodiments, a value indicative of a physiological rate of asubject may be determined by filtering an intensity signal into a lowfrequency component and a high frequency component, determining one ormore metrics for each of the low frequency component and the highfrequency component, comparing the one or more metrics, and selectingeither the low frequency component or the high frequency component. Theone or more metrics may include, for example, a kurtosis value, astandard deviation value, a root mean square value, and/or any othersuitable metric. The intensity signal may be filtered, for example, intoa low frequency component by attenuating frequencies greater thanapproximately 75 BPM, or into a high frequency component by attenuatingfrequencies lesser than approximately 75 BPM. The 75 BPM cut-off isexemplary and any other suitable BPM cutoff can be used to separate theintensity signal into high and low frequency components. In someembodiments, the value indicative of the physiological rate may bedetermined by calculating an autocorrelation sequence based on theselected frequency component, generating a threshold based on theautocorrelation sequence, identifying threshold crossings, anddetermining a difference (e.g., in time or sample number) associatedwith at least two threshold crossings. In some embodiments, theforegoing techniques may be used to determine one or more initializationsettings.

In some embodiments, at least one value indicative of a physiologicalrate of a subject may be determined based on one or more fast startparameters. An autocorrelation sequence may be calculated based on theintensity signal and the one or more fast start parameters. Theautocorrelation sequence may be analyzed to determine the at least onevalue indicative of a physiological rate of the subject. The one or morefast start parameters may include, for example, an autocorrelationtemplate size and/or an autocorrelation template size increment. In someembodiments, more than one autocorrelation sequence may be calculated inseries using autocorrelation templates of different sizes. Theautocorrelation templates may optionally increase in size as the seriesprogresses. Analysis of the autocorrelation sequence may includegenerating a threshold based on the autocorrelation sequence, andidentifying a threshold crossing. In some embodiments, the fast startparameters may be used to determine one or more initialization settings.

BRIEF DESCRIPTION OF THE FIGURES

The above and other features of the present disclosure, its nature andvarious advantages will be more apparent upon consideration of thefollowing detailed description, taken in conjunction with theaccompanying drawings in which:

FIG. 1 shows an illustrative physiological monitoring system, inaccordance with some embodiments of the present disclosure;

FIG. 2 is a block diagram of the illustrative physiological monitoringsystem of FIG. 1 coupled to a subject, in accordance with someembodiments of the present disclosure;

FIG. 3 shows a block diagram of an illustrative signal processing systemin accordance with some embodiments of the present disclosure;

FIG. 4 is a flow diagram of illustrative steps for determininginitialization parameters, calculating a physiological rate, andverifying the rate for output, in accordance with some embodiments ofthe present disclosure;

FIG. 5 is a flow diagram of illustrative steps for determining one ormore settings based on a number of threshold crossings of anautocorrelation, in accordance with some embodiments of the presentdisclosure;

FIG. 6 is a plot of an illustrative autocorrelation of a physiologicalsignal, along with a threshold, in accordance with some embodiments ofthe present disclosure;

FIG. 7 is an illustrative plot of the number of threshold crossings ofthe autocorrelation of FIG. 6 as a function of threshold position, inaccordance with some embodiments of the present disclosure;

FIG. 8 is an illustrative histogram of instances of various numbers ofthreshold, in accordance with some embodiments of the presentdisclosure;

FIG. 9 is a flow diagram of illustrative steps for determining one ormore settings based on analyzing physiological peaks, in accordance withsome embodiments of the present disclosure;

FIG. 10 is a plot of an illustrative filtered photoplethysmographsignal, in accordance with some embodiments of the present disclosure;

FIG. 11 is a plot of an illustrative autocorrelation of thephotoplethysmograph signal of FIG. 10, with several peak shapes notated,in accordance with some embodiments of the present disclosure;

FIG. 12 is a plot of an illustrative filtered photoplethysmographsignal, relatively noisier than the photoplethysmograph signal of FIG.10, in accordance with some embodiments of the present disclosure;

FIG. 13 is a plot of an illustrative autocorrelation of thephotoplethysmograph signal of FIG. 12, with several peak shapes notated,in accordance with some embodiments of the present disclosure;

FIG. 14 is a flow diagram of illustrative steps for determining one ormore settings based on a phase between a physiological signal andmodulated signals, in accordance with some embodiments of the presentdisclosure;

FIG. 15 is a plot of an illustrative filtered photoplethysmographsignal, in accordance with some embodiments of the present disclosure;

FIG. 16 is a plot of an illustrative filtered photoplethysmograph signalof modulated by both cosine and sine functions, in accordance with someembodiments of the present disclosure;

FIG. 17 is a plot of illustrative phase signals generated from modulatedsignals, in accordance with some embodiments of the present disclosure;

FIG. 18 is a flow diagram of illustrative steps for determining one ormore settings based on a cross-correlation of a signal with across-correlation waveform, in accordance with some embodiments of thepresent disclosure;

FIG. 19 is a flow diagram of illustrative steps for generating across-correlation waveform, in accordance with some embodiments of thepresent disclosure;

FIG. 20 is a plot of an illustrative cross-correlation waveform, inaccordance with some embodiments of the present disclosure;

FIG. 21 is a plot of an illustrative window of data of a physiologicalsignal, in accordance with some embodiments of the present disclosure;

FIG. 22 is a plot of an illustrative cross-correlation of anautocorrelation of a window of data with a cross-correlation waveform,in accordance with some embodiments of the present disclosure;

FIG. 23 is a flow diagram of illustrative steps for selecting a segmentof a cross-correlation waveform based on envelope analysis, inaccordance with some embodiments of the present disclosure;

FIG. 24 is a plot of an illustrative cross-correlation output, inaccordance with some embodiments of the present disclosure;

FIG. 25 is a flow diagram of illustrative steps for qualifying a peak ofa cross-correlation waveform based on a standard deviation, inaccordance with some embodiments of the present disclosure;

FIG. 26 is a plot of an illustrative cross-correlation output and athreshold value, in accordance with some embodiments of the presentdisclosure;

FIG. 27 is a flow diagram of illustrative steps for qualifying a peak ofa cross-correlation waveform based on a peak comparison, in accordancewith some embodiments of the present disclosure;

FIG. 28 is a plot of an illustrative cross-correlation output undernoisy conditions, in accordance with some embodiments of the presentdisclosure;

FIG. 29 is a flow diagram of illustrative steps for qualifying a peak ofa cross-correlation waveform based on a segment sum, in accordance withsome embodiments of the present disclosure;

FIG. 30 is a plot of an illustrative pre-processed PPG signal,exhibiting low frequency noise, in accordance with some embodiments ofthe present disclosure;

FIG. 31 is a plot of an illustrative cross-correlation output based inpart on the PPG signal of FIG. 30, in accordance with some embodimentsof the present disclosure;

FIG. 32 is a plot of the sum within each segment of the illustrativecross-correlation output of FIG. 31, in accordance with some embodimentsof the present disclosure;

FIG. 33 is a flow diagram of illustrative steps for identifying asegment of a cross-correlation output based on a segment analysis, inaccordance with some embodiments of the present disclosure;

FIG. 34 is a plot showing one segment of an illustrativecross-correlation output with a segment shape highlighted, in accordancewith some embodiments of the present disclosure;

FIG. 35 is a flow diagram of illustrative steps for providing a combinedautocorrelation of a physiological signal using one or more priorautocorrelations, in accordance with some embodiments of the presentdisclosure;

FIG. 36 is a flow diagram of illustrative steps for providing a combinedautocorrelation using various window sizes and templates, in accordancewith some embodiments of the present disclosure;

FIG. 37 is a flow diagram of illustrative steps for performing across-correlation using a library of cross-correlation waveforms, inaccordance with some embodiments of the present disclosure;

FIG. 38 is a flow diagram of illustrative steps for qualifying ordisqualifying initialization parameters using a cross-correlation, inaccordance with some embodiments of the present disclosure;

FIG. 39 is a plot of an illustrative PPG signal showing one pulse of asubject, in accordance with some embodiments of the present disclosure;

FIG. 40 is a plot of an illustrative template derived from the PPGsignal of FIG. 39 with baseline removed, in accordance with someembodiments of the present disclosure;

FIG. 41 is a plot of the illustrative template of FIG. 40 scaled overthe domain to different sizes for use as templates in performing across-correlation, in accordance with some embodiments of the presentdisclosure;

FIG. 42 is a plot of output of an illustrative cross-correlation betweena photoplethysmograph signal and a predefined template, in accordancewith some embodiments of the present disclosure;

FIG. 43 is a flow diagram of illustrative steps for qualifying ordisqualifying initialization parameters based on an analysis of twosegments of a cross-correlation output, in accordance with someembodiments of the present disclosure;

FIG. 44 is a plot of an illustrative cross-correlation output, showingseveral reference points for generating a symmetry curve, in accordancewith some embodiments of the present disclosure;

FIG. 45 is a plot of an illustrative symmetry curve generated using twosegments of a cross-correlation, in accordance with some embodiments ofthe present disclosure;

FIG. 46 is a flow diagram of illustrative steps for qualifying ordisqualifying initialization parameters based on an analysis of offsetsegments of a cross-correlation output, in accordance with someembodiments of the present disclosure;

FIG. 47 shows multiple plots of illustrative cross-correlation outputsand corresponding symmetry curves, radial curves, radius calculations,and angle calculations, in accordance with some embodiments of thepresent disclosure;

FIG. 48 is a flow diagram of illustrative steps for qualifying ordisqualifying initialization parameters based on an areas of positiveand negative portions of segments of a cross-correlation output, inaccordance with some embodiments of the present disclosure;

FIG. 49 is a plot of an illustrative cross-correlation output with thecorrect rate locked-in, in accordance with some embodiments of thepresent disclosure;

FIG. 50 is a plot of an illustrative cross-correlation output withdouble the correct rate locked-in, in accordance with some embodimentsof the present disclosure;

FIG. 51 is a plot of an illustrative cross-correlation output with onehalf the correct rate locked-in, in accordance with some embodiments ofthe present disclosure;

FIG. 52 is a plot of illustrative difference calculations of the AreaTest, and a plot of illustrative calculated rates indicative of anactual physiological pulse, in accordance with some embodiments of thepresent disclosure;

FIG. 53 is a flow diagram of illustrative steps for qualifying ordisqualifying initialization parameters based on a filteredphysiological signal, in accordance with some embodiments of the presentdisclosure;

FIG. 54 is a flow diagram of illustrative steps for qualifying ordisqualifying initialization parameters based on a comparison of areasof two segments of a cross-correlation output, in accordance with someembodiments of the present disclosure;

FIG. 55 is a flow diagram of illustrative steps for qualifying ordisqualifying initialization parameters based on statistical propertiesof a cross-correlation output, in accordance with some embodiments ofthe present disclosure;

FIG. 56 is a flow diagram of illustrative steps for analyzingqualification metrics based on scaled templates of different lengths, inaccordance with some embodiments of the present disclosure;

FIG. 57 is a flow diagram of illustrative steps for selecting one ormore templates, and analyzing qualification metrics based on scaledtemplates, in accordance with some embodiments of the presentdisclosure;

FIG. 58 is a flow diagram of illustrative steps for determining whetherto change the Search Mode technique or to transition from Search Mode toLocked Mode, in accordance with some embodiments of the presentdisclosure;

FIG. 59 is a flow diagram of illustrative steps for determining whetherto transition from Search Mode to Locked Mode, in accordance with someembodiments of the present disclosure;

FIG. 60 is a flow diagram of illustrative steps for determining whetherto transition from Search Mode to Locked Mode using multiple techniques,in accordance with some embodiments of the present disclosure;

FIG. 61 is a flow diagram of illustrative steps for modifyingphysiological data using an envelope, in accordance with someembodiments of the present disclosure;

FIG. 62 is a flow diagram of illustrative steps for modifyingphysiological data by subtracting a trend, in accordance with someembodiments of the present disclosure;

FIG. 63 is a plot of an illustrative window of data with the meanremoved, in accordance with some embodiments of the present disclosure;

FIG. 64 is a plot of an illustrative window of data and a quadratic fit,in accordance with some embodiments of the present disclosure;

FIG. 65 is a plot of the illustrative window of data of FIG. 64 with thequadratic fit subtracted, in accordance with some embodiments of thepresent disclosure;

FIG. 66 is a plot of an illustrative modified window of data derivedfrom an original window of data with the mean subtracted, in accordancewith some embodiments of the present disclosure;

FIG. 67 is a plot of an illustrative modified window of data derivedfrom the same original window of data as FIG. 66 with a linear baselinesubtracted, in accordance with some embodiments of the presentdisclosure;

FIG. 68 is a plot of an illustrative modified window of data derivedfrom the same original windows of data as FIGS. 66 and 67 with aquadratic baseline subtracted, in accordance with some embodiments ofthe present disclosure;

FIG. 69 is a plot of an illustrative cross-correlation output,calculated using a particular window of data with the mean removed, inaccordance with some embodiments of the present disclosure;

FIG. 70 is a plot of an illustrative cross-correlation output,calculated using the same particular window of data of FIG. 69 with alinear fit removed, in accordance with some embodiments of the presentdisclosure;

FIG. 71 is a plot of an illustrative cross-correlation output,calculated using the same particular window of data of FIGS. 69 and 70with a quadratic fit removed, in accordance with some embodiments of thepresent disclosure;

FIG. 72 is a flow diagram of illustrative steps for determining aphysiological rate from threshold crossings based on a physiologicalsignal, in accordance with some embodiments of the present disclosure;

FIG. 73 is a plot of an illustrative autocorrelation output, with a RateCalculation threshold shown, in accordance with some embodiments of thepresent disclosure;

FIG. 74 is a plot of an illustrative binary signal, generated from theautocorrelation output of FIG. 73, which may be used to calculate aphysiological pulse rate, in accordance with some embodiments of thepresent disclosure;

FIG. 75 is a flow diagram of illustrative steps for determining athreshold based on a Constant False Alarm Rate (CFAR) setting, inaccordance with some embodiments of the present disclosure;

FIG. 76 shows an illustrative CFAR window, including the sample undertest, guard samples, and base samples, in accordance with someembodiments of the present disclosure;

FIG. 77 is a plot of an illustrative autocorrelation output, with threeCFAR windows shown, in accordance with some embodiments of the presentdisclosure;

FIG. 78 is a plot of the illustrative autocorrelation output of FIG. 77,with a threshold generated based in part on the CFAR windows of FIG. 77,in accordance with some embodiments of the present disclosure;

FIG. 79 is a plot of an illustrative autocorrelation output and a RateCalculation threshold, in accordance with some embodiments of thepresent disclosure;

FIG. 80 is a plot of an illustrative binary signal generated based onthe autocorrelation output and Rate Calculation threshold of FIG. 79, inaccordance with some embodiments of the present disclosure;

FIG. 81 is a flow diagram of illustrative steps for qualifying anautocorrelation template size to perform an autocorrelation, inaccordance with some embodiments of the present disclosure;

FIG. 82 is a flow diagram of illustrative steps for selecting anautocorrelation template, in accordance with some embodiments of thepresent disclosure;

FIG. 83 is a flow diagram of illustrative steps for classifying aphysiological signal to be used in Search Mode and/or Locked Mode, inaccordance with some embodiments of the present disclosure;

FIG. 84 is a flow diagram of illustrative steps for classifying aphysiological signal, in accordance with some embodiments of the presentdisclosure;

FIG. 85 is a flow diagram of illustrative steps for providing a FastStart, in accordance with some embodiments of the present disclosure;

FIG. 86 is a flow diagram of illustrative steps for implementing SearchMode and Locked Mode, in accordance with some embodiments of the presentdisclosure;

FIG. 87 is a flow diagram of illustrative steps for implementing SearchMode, in accordance with some embodiments of the present disclosure; and

FIG. 88 is a flow diagram of illustrative steps for implementing LockedMode, in accordance with some embodiments of the present disclosure.

DETAILED DESCRIPTION OF THE FIGURES

The present disclosure is directed towards determining physiologicalinformation including a physiological rate. A physiological monitor maydetermine one or more physiological parameters such as, for example,pulse rate, respiration rate, blood oxygen saturation, blood pressure,or any other suitable parameters, based on signals received from one ormore sensors. For example, a physiological monitor may analyzephotoplethysmographic (PPG) signals for oscillometric behaviorcharacterized by a pulse rate, a respiration rate, or both.Physiological signals may include one or more noise components, whichmay include the effects of ambient light, 60 Hz electromagneticradiation from powered devices, subject movement, any othernon-physiological signal component or undesired physiological signalcomponent, or any combination thereof.

In some circumstances, the determination of a pulse rate fromphotoplethysmographic information may present challenges. Typical pulserates range from about 20 to 300 BM for human subjects. For example, thepulse rate of a neonate may be relatively high (e.g., 130-180 BPM)compared to that of a resting adult (e.g., 50-80 BM). Various sources ofnoise may obscure the pulse rate. For example, motion artifacts fromsubject movement may occur over time scales similar to those of thepulse rate of the subject (e.g., on the order of 1 Hertz). Subjectmovement can prove especially troublesome in measuring pulse rates ofneonates, who tend to exhibit significant movement at times duringmeasurements. Significant movement can cause the noise component of thePPG signal to be larger and in some cases significantly larger than thephysiological pulse component.

Other factors may also present challenges in determining pulse rate. Forexample, the shape of physiological pulses can vary significantly notonly between subjects, but also with time, position, and physicalorientation for a given subject. Moreover, certain pulse shapes inparticular may make it difficult to determine the correct pulse rate. Asan example, deep dicrotic notches may cause a single pulse to appearsimilar to two consecutive pulses and thus it may cause one to believethat the pulse rate is double the actual rate. Low perfusion is anotherfactor that can present challenges. A subject with low perfusiontypically has low-amplitude physiological pulses and therefore PPGsignals derived from such subjects may be more susceptible to noise thanPPG signals derived from other subjects.

The present disclosure discloses techniques for reliably determiningrate information from a physiological signal and in particular todetermining pulse rate from photoplethysmographic information. While thetechniques are disclosed in some embodiments as being implemented in thecontext of oximeters, it will be understood that any suitable processingdevice may be used in accordance with the present disclosure.

An oximeter is a medical device that may determine the oxygen saturationof the blood. One common type of oximeter is a pulse oximeter, which mayindirectly measure the oxygen saturation of a subject's blood (asopposed to measuring oxygen saturation directly by analyzing a bloodsample taken from the subject). Pulse oximeters may be included inphysiological monitoring systems that measure and display various bloodflow characteristics including, but not limited to, the oxygensaturation of hemoglobin in arterial blood. Such physiologicalmonitoring systems may also measure and display additional physiologicalparameters, such as a subject's pulse rate, respiration rate, and bloodpressure.

An oximeter may include a light sensor that is placed at a site on asubject, typically a fingertip, toe, forehead or earlobe, or in the caseof a neonate, across a foot. The oximeter may use a light source to passlight through blood perfused tissue and photoelectrically sense thetransmission of the light in the tissue (e.g., which may be indicativeof absorbed light). In addition, locations which are not typicallyunderstood to be optimal for pulse oximetry may be used in someembodiments. For example, additional suitable sensor locations include,without limitation, the neck to monitor carotid artery pulsatile flow,the wrist to monitor radial artery pulsatile flow, the inside of asubject's thigh to monitor femoral artery pulsatile flow, the ankle tomonitor tibial artery pulsatile flow, and around or in front of the ear.Suitable sensors for these locations may include sensors for sensingabsorbed light based on detecting reflected light (e.g., a foreheadsensor). In all suitable locations, for example, the oximeter maymeasure the intensity of light that is received at the light sensor as afunction of time. The oximeter may also include sensors at multiplelocations. A signal representing light intensity versus time or amathematical manipulation of this signal (e.g., a scaled versionthereof, a log taken thereof, a scaled version of a log taken thereof,etc.) may be referred to as the photoplethysmograph (PPG) signal. Inaddition, the term “PPG signal,” as used herein, may also refer to anabsorption signal (i.e., representing the amount of light absorbed bythe tissue), a transmission signal (i.e., representing the amount oflight transmitted by the tissue), or any suitable mathematicalmanipulation thereof. The light intensity or the amount of lightabsorbed may then be used to calculate any of a number of physiologicalparameters, including an amount of a blood constituent (e.g.,oxyhemoglobin) being measured as well as a pulse rate and when eachindividual pulse occurs.

In some applications, the light passed through the tissue is selected tobe of one or more wavelengths that are absorbed by the blood in anamount representative of the amount of the blood constituent present inthe blood. The amount of light passed through the tissue varies inaccordance with the changing amount of blood constituent in the tissueand the related light absorption. Red and infrared (IR) wavelengths maybe used because it has been observed that highly oxygenated blood willabsorb relatively less Red light and more IR light than blood with alower oxygen saturation. By comparing the intensities of two wavelengthsat different points in the pulse cycle, it is possible to estimate theblood oxygen saturation of hemoglobin in arterial blood.

When the measured blood parameter is the oxygen saturation ofhemoglobin, a convenient starting point assumes a saturation calculationbased on Lambert-Beer's law. The following notation will be used herein:

I(λ,t)=I ₀(λ)exp(−(sβ ₀(λ)+(1−s)β_(r)(λ))l(t))  (1)

where:λ=wavelength;t=time;I=intensity of light detected;I₀=intensity of light transmitted;s=oxygen saturation;β₀,β_(r)=empirically derived absorption coefficients; andl(t)=a combination of concentration and path length from emitter todetector as a function of time.

The traditional approach measures light absorption at two wavelengths(e.g., Red and IR), and then calculates saturation by solving for the“ratio of ratios” as follows.

1. The natural logarithm of Eq. 1 is taken (“log” will be used torepresent the natural logarithm) for IR and Red to yield

log I=log I ₀−(sβ ₀+(1−s)β_(r))l.  (2)

2. Eq. 2 is then differentiated with respect to time to yield

$\begin{matrix}{\frac{{\log}\; I}{t} = {{- \left( {{s\; \beta_{o}} + {\left( {1 - s} \right)\beta_{r}}} \right)}{\frac{l}{t}.}}} & (3)\end{matrix}$

3. Eq. 3, evaluated at the Red wavelength λ_(R), is divided by Eq. 3evaluated at the IR wavelength λ_(IR) in accordance with

$\begin{matrix}{\frac{{\log}\; {{I\left( \lambda_{R} \right)}/{t}}}{{\log}\; {{I\left( \lambda_{IR} \right)}/{t}}} = {\frac{{s\; {\beta_{o}\left( \lambda_{R} \right)}} + {\left( {1 - s} \right){\beta_{r}\left( \lambda_{R} \right)}}}{{s\; {\beta_{o}\left( \lambda_{IR} \right)}} + {\left( {1 - s} \right){\beta_{r}\left( \lambda_{IR} \right)}}}.}} & (4)\end{matrix}$

4. Solving for s yields

$\begin{matrix}{s = {\frac{{\frac{{\log}\; {I\left( \lambda_{IR} \right)}}{t}{\beta_{r}\left( \lambda_{R} \right)}} - {\frac{{\log}\; {I\left( \lambda_{R} \right)}}{t}{\beta_{r}\left( \lambda_{IR} \right)}}}{{\frac{{\log}\; {I\left( \lambda_{R} \right)}}{t}\begin{pmatrix}{{\beta_{o}\left( \lambda_{IR} \right)} -} \\{\beta_{r}\left( \lambda_{IR} \right)}\end{pmatrix}} - {\frac{{\log}\; {I\left( \lambda_{IR} \right)}}{t}\left( {{\beta_{o}\left( \lambda_{R} \right)} - {\beta_{r}\left( \lambda_{R} \right)}} \right)}}.}} & (5)\end{matrix}$

5. Note that, in discrete time, the following approximation can be made:

$\begin{matrix}{\frac{{\log}\; {I\left( {\lambda,t} \right)}}{t} \simeq {{\log \; {I\left( {\lambda,t_{2}} \right)}} - {\log \; {{I\left( {\lambda,t_{1}} \right)}.}}}} & (6)\end{matrix}$

6. Rewriting Eq. 6 by observing that log A−log B=log(A/B) yields

$\begin{matrix}{\frac{{\log}\; {I\left( {\lambda,t} \right)}}{t} \simeq {{\log \left( \frac{I\left( {t_{2},\lambda} \right)}{I\left( {t_{1},\lambda} \right)} \right)}.}} & (7)\end{matrix}$

7. Thus, Eq. 4 can be expressed as

$\begin{matrix}{{{\frac{\frac{{\log}\; {I\left( \lambda_{R} \right)}}{t}}{\frac{{\log}\; {I\left( \lambda_{IR} \right)}}{t}} \simeq \frac{\log \left( \frac{I\left( {t_{1},\lambda_{R}} \right)}{I\left( {t_{2},\lambda_{R}} \right)} \right)}{\log \left( \frac{I\left( {t_{1},\lambda_{IR}} \right)}{I\left( {t_{2},\lambda_{IR}} \right)} \right)}} = R},} & (8)\end{matrix}$

where R represents the “ratio of ratios.”8. Solving Eq. 4 for s using the relationship of Eq. 5 yields

$\begin{matrix}{s = {\frac{{\beta_{r}\left( \lambda_{R} \right)} - {R\; {\beta_{r}\left( \lambda_{IR} \right)}}}{{R\left( {{\beta_{o}\left( \lambda_{IR} \right)} - {\beta_{r}\left( \lambda_{IR} \right)}} \right)} - {\beta_{o}\left( \lambda_{R} \right)} + {\beta_{r}\left( \lambda_{R} \right)}}.}} & (9)\end{matrix}$

9. From Eq. 8, R can be calculated using two points (e.g., PPG maximumand minimum), or a family of points. One method applies a family ofpoints to a modified version of Eq. 8. Using the relationship

$\begin{matrix}{{\frac{{\log}\; I}{t} = \frac{{I}/{t}}{I}},} & (10)\end{matrix}$

Eq. 8 becomes

$\begin{matrix}\begin{matrix}{\frac{\frac{{\log}\; {I\left( \lambda_{R} \right)}}{t}}{\frac{{\log}\; {I\left( \lambda_{IR} \right)}}{t}} \simeq \frac{\frac{{I\left( {t_{2},\lambda_{R}} \right)} - {I\left( {t_{1},\lambda_{R}} \right)}}{I\left( {t_{1},\lambda_{R}} \right)}}{\frac{{I\left( {t_{2},\lambda_{IR}} \right)} - {I\left( {t_{1},\lambda_{IR}} \right)}}{I\left( {t_{1},\lambda_{IR}} \right)}}} \\{= \frac{\left\lbrack {{I\left( {t_{2},\lambda_{R}} \right)} - {I\left( {t_{1},\lambda_{R}} \right)}} \right\rbrack {I\left( {t_{1},\lambda_{IR}} \right)}}{\left\lbrack {{I\left( {t_{2},\lambda_{IR}} \right)} - {I\left( {t_{1},\lambda_{IR}} \right)}} \right\rbrack {I\left( {t_{1},\lambda_{R}} \right)}}} \\{{= R},}\end{matrix} & (11)\end{matrix}$

which defines a cluster of points whose slope of y versus x will give Rwhen

x=[I(t ₂,λ_(IR))−I(t ₁,λ_(IR))]I(t ₁,λ_(R)),  (12)

y=[I(t ₂,λ_(R))−I(t ₁,λ_(R))]I(t ₁,λ_(IR)).  (13)

Once R is determined or estimated, for example, using the techniquesdescribed above, the blood oxygen saturation can be determined orestimated using any suitable technique for relating a blood oxygensaturation value to R. For example, blood oxygen saturation can bedetermined from empirical data that may be indexed by values of R,and/or it may be determined from curve fitting and/or otherinterpolative techniques.

Pulse rate can be determined from the IR light signal, the Red lightsignal, any other suitable wavelength light signal, or a combination oflight signals.

FIG. 1 is a perspective view of an embodiment of a physiologicalmonitoring system 10. System 10 may include sensor unit 12 and monitor14. In some embodiments, sensor unit 12 may be part of an oximeter.Sensor unit 12 may include an emitter 16 for emitting light at one ormore wavelengths into a subject's tissue. A detector 18 may also beprovided in sensor 12 for detecting the light originally from emitter 16that emanates from the subject's tissue after passing through thetissue. Any suitable physical configuration of emitter 16 and detector18 may be used. In an embodiment, sensor unit 12 may include multipleemitters and/or detectors, which may be spaced apart. System 10 may alsoinclude one or more additional sensor units (not shown) which may takethe form of any of the embodiments described herein with reference tosensor unit 12. An additional sensor unit may be the same type of sensorunit as sensor unit 12, or a different sensor unit type than sensor unit12. Multiple sensor units may be capable of being positioned at twodifferent locations on a subject's body; for example, a first sensorunit may be positioned on a subject's forehead, while a second sensorunit may be positioned at a subject's fingertip.

Sensor units may each detect any signal that carries information about asubject's physiological state, such as arterial line measurements or thepulsatile force exerted on the walls of an artery using, for example,oscillometric methods with a piezoelectric transducer. According toanother embodiment, system 10 may include a plurality of sensors forminga sensor array in lieu of either or both of the sensor units. Each ofthe sensors of a sensor array may be a complementary metal oxidesemiconductor (CMOS) sensor. Alternatively, each sensor of an array maybe a charged coupled device (CCD) sensor. In some embodiments, a sensorarray may be made up of a combination of CMOS and CCD sensors. The CCDsensor may comprise a photoactive region and a transmission region forreceiving and transmitting data whereas the CMOS sensor may be made upof an integrated circuit having an array of pixel sensors. In someembodiments, each pixel may have a photodetector and an activeamplifier. In some embodiments, a group of pixels may share anamplifier. It will be understood that any type of sensor, including anytype of physiological sensor, may be used in one or more sensor units inaccordance with the systems and techniques disclosed herein. It isunderstood that any number of sensors measuring any number ofphysiological signals may be used to determine physiological informationin accordance with the techniques described herein.

In some embodiments, emitter 16 and detector 18 may be on opposite sidesof a digit such as a finger or toe, in which case the light that isemanating from the tissue has passed completely through the digit. In anembodiment, emitter 16 and detector 18 may be arranged so that lightfrom emitter 16 penetrates the tissue and is attenuated by the tissueand transmitted to detector 18, such as in a sensor designed to obtainpulse oximetry data from a subject's forehead.

In some embodiments, sensor unit 12 may be connected to and draw itspower from monitor 14 as shown. In another embodiment, the sensor may bewirelessly connected to monitor 14 and include its own battery orsimilar power supply (not shown). Monitor 14 may be configured tocalculate physiological parameters (e.g., pulse rate, blood pressure,blood oxygen saturation) based on data relating to light emission anddetection received from one or more sensor units such as sensor unit 12.In an alternative embodiment, the calculations may be performed on thesensor units or an intermediate device and the result of thecalculations may be passed to monitor 14. Further, monitor 14 mayinclude a display 20 configured to display the physiological parametersor other information about the system. In the embodiment shown, monitor14 may also include a speaker 22 to provide an audible sound that may beused in various other embodiments, such as for example, sounding anaudible alarm in the event that a subject's physiological parameters arenot within a predefined normal range. In some embodiments, the monitor14 includes a blood pressure monitor. In some embodiments, the system 10includes a stand-alone blood pressure monitor in communication with themonitor 14 via a cable or a wireless network link.

In some embodiments, sensor unit 12 may be communicatively coupled tomonitor 14 via a cable 24. In some embodiments, a wireless transmissiondevice (not shown) or the like may be used instead of or in addition tocable 24.

In the illustrated embodiment, system 10 includes a multi-parameterphysiological monitor 26. The monitor 26 may include a cathode ray tubedisplay, a flat panel display (as shown by display 28) such as a liquidcrystal display (LCD) or a plasma display, or may include any other typeof monitor now known or later developed. Multi-parameter physiologicalmonitor 26 may be configured to calculate physiological parameters andto provide a display 28 for information from monitor 14 and from othermedical monitoring devices or systems (not shown). For example,multi-parameter physiological monitor 26 may be configured to displaypulse rate information from monitor 14, an estimate of a subject's bloodoxygen saturation generated by monitor 14 (referred to as an “SpO₂”measurement), and blood pressure from monitor 14 on display 28.Multi-parameter physiological monitor 26 may include a speaker 30.

Monitor 14 may be communicatively coupled to multi-parameterphysiological monitor 26 via a cable 32 or 34 that is coupled to asensor input port or a digital communications port, respectively and/ormay communicate wirelessly (not shown). In addition, monitor 14 and/ormulti-parameter physiological monitor 26 may be coupled to a network toenable the sharing of information with servers or other workstations(not shown). Monitor 14 and/or multi-parameter physiological monitor 26may be powered by a battery (not shown) or by a conventional powersource such as a wall outlet. In some embodiments, monitor 14, monitor26, or both, may include one or more communications ports (not shown inFIG. 1) such as, for example, universal serial bus (USB) ports, ethernetports, WIFI transmitters/receivers, RS232 ports, any other suitablecommunications ports, or any combination thereof. In some embodiments,monitor 14, monitor 26, or both, may include memory (not shown inFIG. 1) such as, for example, a hard disk, flash memory (e.g., amultimedia card (MMC), a Secure Digital (SD) card), read only memory,any other suitable memory, any suitable communications ports forcommunicating with memory (e.g., a USB port for excepting flash memorydrives, an Ethernet port for communicating with a remote server), or anycombination thereof.

FIG. 2 is a block diagram of a physiological monitoring system, such asphysiological monitoring system 10 of FIG. 1, which may be coupled to asubject 40 in accordance with an embodiment. Certain illustrativecomponents of sensor unit 12 and monitor 14 are illustrated in FIG. 2.

Sensor unit 12 may include emitter 16, detector 18, and encoder 42. Inthe embodiment shown, emitter 16 may be configured to emit at least twowavelengths of light (e.g., Red and IR) into a subject's tissue 40.Hence, emitter 16 may include a Red light emitting light source such asRed light emitting diode (LED) 44 and an IR light emitting light sourcesuch as IR LED 46 for emitting light into the subject's tissue 40 at thewavelengths used to calculate the subject's physiological parameters. Insome embodiments, the Red wavelength may be between about 600 nm andabout 700 nm, and the IR wavelength may be between about 800 nm andabout 1000 nm. In some embodiments, in which a sensor array is used inplace of a single sensor, each sensor may be configured to emit a singlewavelength. For example, a first sensor emits only a Red light while asecond emits only an IR light. In another example, the wavelengths oflight used are selected based on the specific location of the sensor.

It will be understood that, as used herein, the term “light” may referto energy produced by radiation sources and may include one or more ofradio, microwave, millimeter wave, infrared, visible, ultraviolet, gammaray or X-ray electromagnetic radiation. As used herein, light may alsoinclude electromagnetic radiation having any wavelength within theradio, microwave, infrared, visible, ultraviolet, or X-ray spectra, andthat any suitable wavelength of electromagnetic radiation may beappropriate for use with the present techniques. Detector 18 may bechosen to be specifically sensitive to the chosen targeted energyspectrum of the emitter 16.

In some embodiments, detector 18 may be configured to detect theintensity of light at the Red and IR wavelengths. Alternatively, eachsensor in the array may be configured to detect intensity at a singlewavelength. In operation, light may enter detector 18 after beingattenuated (e.g., absorbed, scattered) by the subject's tissue 40.Detector 18 may convert the intensity of the received light into anelectrical signal. The light intensity is related to the absorptionand/or reflected of light in the tissue 40. That is, when more light ata certain wavelength is absorbed or reflected, less or more light ofthat wavelength is received from the tissue by the detector 18. Afterconverting the received light to an electrical signal, detector 18 maysend the signal to monitor 14, where physiological parameters may becalculated based on the absorption of the Red and IR wavelengths in thesubject's tissue 40.

In some embodiments, encoder 42 may contain information about sensor 12,such as sensor type (e.g., whether the sensor is intended for placementon a forehead or digit), the wavelengths of light emitted by emitter 16,power requirements or limitations of emitter 16, or other suitableinformation. This information may be used by monitor 14 to selectappropriate algorithms, lookup tables and/or calibration coefficientsstored in monitor 14 for calculating the subject's physiologicalparameters.

In some embodiments, encoder 42 may contain information specific tosubject 40, such as, for example, the subject's age, weight, anddiagnosis. Information regarding a subject's characteristics may allowmonitor 14 to determine, for example, subject-specific threshold rangesin which the subject's physiological parameter measurements should falland to enable or disable additional physiological parameter algorithms.This information may also be used to select and provide coefficients forequations from which, for example, pulse rate, blood pressure, and othermeasurements may be determined based on the signal or signals receivedat sensor unit 12. For example, some pulse oximetry sensors rely onequations to relate an area under a portion of a PPG signalcorresponding to a physiological pulse to determine blood pressure.These equations may contain coefficients that depend upon a subject'sphysiological characteristics as stored in encoder 42. Encoder 42 may,for instance, be a coded resistor which stores values corresponding tothe type of sensor unit 12 or the type of each sensor in the sensorarray, the wavelengths of light emitted by emitter 16 on each sensor ofthe sensor array, and/or the subject's characteristics. In someembodiments, encoder 42 may include a memory on which one or more of thefollowing information may be stored for communication to monitor 14: thetype of the sensor unit 12; the wavelengths of light emitted by emitter16; the particular wavelength each sensor in the sensor array ismonitoring; a signal threshold for each sensor in the sensor array; anyother suitable information; or any combination thereof. In someembodiments, encoder 42 may include an identifying component such as,for example, a radio-frequency identification (RFID) tag that may beread by decoder 74.

In some embodiments, signals from detector 18 and encoder 42 may betransmitted to monitor 14. In the embodiment shown, monitor 14 mayinclude a general-purpose microprocessor 48, FPGA 49, or both, connectedto an internal bus 50. In some embodiments, monitor 14 may include oneor more microprocessors, digital signal processors (DSPs), or both.Microprocessor 48 may be adapted to execute software, which may includean operating system and one or more applications, as part of performingthe functions described herein. Also connected to bus 50 may be aread-only memory (ROM) 52, a random access memory (RAM) 54, removablememory 53, user inputs 56, display 20, and speaker 22.

RAM 54, ROM 52, and removable memory 53 are illustrated by way ofexample (e.g., communications interface 90, flash memory, digital logicarray, field programmable gate array (FPGA), or any other suitablememory), and not limitation. Any suitable computer-readable media may beused in the system for data storage. Computer-readable media are capableof storing information that can be interpreted by microprocessor 48,FPGA 49, or both. This information may be data or may take the form ofcomputer-executable instructions, such as software applications, thatcause the microprocessor to perform certain functions and/orcomputer-implemented methods. Depending on the embodiment, suchcomputer-readable media may include computer storage media andcommunication media. Computer storage media may include volatile andnon-volatile, writable and non-writable, and removable and non-removablemedia implemented in any method or technology for storage of informationsuch as computer-readable instructions, data structures, program modulesor other data. Computer storage media may include, but is not limitedto, RAM, ROM, EPROM, EEPROM, flash memory or other solid state memorytechnology, CD-ROM, DVD, or other optical storage, magnetic cassettes,magnetic tape, magnetic disk storage or other magnetic storage devices,or any other medium which can be used to store the desired informationand which can be accessed by components of the system.

In the embodiment shown, a time processing unit (TPU) 58 may providetiming control signals to light drive circuitry 60, which may controlwhen emitter 16 is illuminated and multiplexed timing for Red LED 44 andIR LED 46. TPU 58 may also control the gating-in of signals fromdetector 18 through amplifier 62 and switching circuit 64. These signalsare sampled at the proper time, depending upon which light source isilluminated. In some embodiments, microprocessor 48, FPGA 49, or both,may de-multiplex the signal from detector 18 using de-multiplexingtechniques such as time-division, frequency-division, code division, orany other suitable de-multiplexing technique. In some embodiments,microprocessor 48, FPGA 49, or both, may perform the functions of TPU 58using suitable timing signals and multiplexing/de-multiplexingalgorithms, and accordingly TPU 58 need not be included. The receivedsignal from detector 18 may be passed through amplifier 66, low passfilter 68, and analog-to-digital converter 70. The digital data may thenbe stored in a queued serial module (QSM) 72 (or buffer such as a firstin first out (FIFO) buffer) for later downloading to RAM 54 as QSM 72fills up. A window of data may be selected from the data stored in thebuffer for further processing. In some embodiments, there may bemultiple separate parallel paths having components equivalent toamplifier 62, switching circuit 64, amplifier 66, filter 68, and/or A/Dconverter 70 for multiple light wavelengths or spectra received. In someembodiments, a filter (e.g., an analog filter) may be included (notshown) between amplifier 62 and switching circuit 64.

In an embodiment, microprocessor 48 may determine the subject'sphysiological parameters, such as pulse rate, SpO₂, and/or bloodpressure, using various algorithms and/or look-up tables based on thevalue of the received signals and/or data corresponding to the lightreceived by detector 18. Signals corresponding to information aboutsubject 40, and particularly about the intensity of attenuated lightemanating from a subject's tissue over time, may be transmitted fromencoder 42 to decoder 74. These signals may include, for example,encoded information relating to subject characteristics. Decoder 74 maytranslate these signals to enable the microprocessor to determine thethresholds based on algorithms or look-up tables stored in ROM 52. Insome embodiments, user inputs 56 may be used enter information, selectone or more options, provide a response, input settings, any othersuitable inputting function, or any combination thereof. User inputs 56may be used to enter information about the subject, such as age, weight,height, diagnosis, medications, treatments, and so forth. In someembodiments, display 20 may exhibit a list of values which may generallyapply to the subject, such as, for example, age ranges or medicationfamilies, which the user may select using user inputs 56.

Calibration device 80, which may be powered by monitor 14 via a coupling82, a battery, or by a conventional power source such as a wall outlet,may include any suitable signal calibration device. Calibration device80 may be communicatively coupled to monitor 14 via communicativecoupling 82, and/or may communicate wirelessly (not shown). In someembodiments, calibration device 80 is completely integrated withinmonitor 14. In some embodiments, calibration device 80 may include amanual input device (not shown) used by an operator to manually inputreference signal measurements obtained from some other source (e.g., anexternal invasive or non-invasive physiological measurement system).Calibration device 80 may be coupled to one or more components ofmonitor 14 to calibrate monitor 14.

Communications (“Comm”) interface 90 may include any suitable hardware,software, or both, which may allow physiological monitoring system 10(e.g., monitor 14, monitor 26) to communicate with electronic circuitry,a device, a network, or any combinations thereof. Communicationsinterface 90 may include one or more receivers, transmitters,transceivers, antennas, plug-in connectors, ports, communications buses,communications protocols, device identification protocols, any othersuitable hardware or software, or any combination thereof.Communications interface 90 may be configured to allow wiredcommunication (e.g., using USB, RS-232 or other standards), wirelesscommunication (e.g., using WiFi, IR, WiMax, BLUETOOTH, UWB, or otherstandards), or both. For example, communications interface 90 may beconfigured using a universal serial bus (USB) protocol (e.g., USB 1.0,USB 2.0, USB 3.0), and may be configured to couple to other devices(e.g., remote memory devices storing templates) using a four-pin USBstandard Type-A connector (e.g., plug and/or socket) and cable. In afurther example, communications interface 90 may be configured to accessa database server, which may contain a template database. In someembodiments, communications interface 90 may include an internal bussuch as, for example, one or more slots for insertion of expansion cards(e.g., to expand the capabilities of monitor 14, monitor 26, or both).

As described above, the optical signal attenuated by the tissue can bedegraded by noise, among other sources, an electrical signal derivedthereof can also be degraded by noise. One source of noise is ambientlight that reaches the light detector. Another source of noise in anintensity signal is electromagnetic coupling from other electronicinstruments. Movement of the subject also introduces noise and affectsthe signal. For example, the contact between the detector and the skin,or the emitter and the skin, can be temporarily disrupted when movementcauses either to move away from the skin. In addition, because blood isa fluid, it responds differently than the surrounding tissue to inertialeffects, thus resulting in momentary changes in volume at the point towhich the oximeter probe is attached.

Noise (e.g., from subject movement) can degrade a sensor signal reliedupon by a care provider, without the care provider's awareness. This isespecially true if the monitoring of the subject is remote, the motionis too small to be observed, or the care provider is watching theinstrument or other parts of the subject, and not the sensor site.Analog and/or digital processing of sensor signals (e.g., PPG signals)may involve operations that reduce the amount of noise present in thesignals or otherwise identify noise components in order to prevent themfrom affecting measurements of physiological parameters derived from thesensor signals.

It will be understood that the present disclosure is applicable to anysuitable signal and that PPG signals are used merely for illustrativepurposes. Those skilled in the art will recognize that the presentdisclosure has wide applicability to other signals including, but notlimited to, other biosignals (e.g., electrocardiograms,electroencephalograms, electrogastrograms, electromyograms, pulse ratesignals, pathological signals, ultrasound signals, any other suitablebiosignals), or any combination thereof.

FIG. 3 is an illustrative signal processing system 300 in accordancewith an embodiment that may implement the signal processing techniquesdescribed herein. In some embodiments, signal processing system 300 maybe included in a physiological monitoring system (e.g., physiologicalmonitoring system 10 of FIGS. 1-2). In the illustrated embodiment, inputsignal generator 310 generates an input signal 316. As illustrated,input signal generator 310 may include pre-processor 320 coupled tosensor 318, which may provide input signal 316. In some embodiments,input signal 316 may include one or more intensity signals based on adetector output. In some embodiments, pre-processor 320 may be anoximeter and input signal 316 may be a PPG signal. In an embodiment,pre-processor 320 may be any suitable signal processing device and inputsignal 316 may include PPG signals and one or more other physiologicalsignals, such as an electrocardiogram (ECG) signal. It will beunderstood that input signal generator 310 may include any suitablesignal source, signal generating data, signal generating equipment, orany combination thereof to produce signal 316. Signal 316 may be asingle signal, or may be multiple signals transmitted over a singlepathway or multiple pathways.

Pre-processor 320 may apply one or more signal processing operations tothe signal generated by sensor 318. For example, pre-processor 320 mayapply a pre-determined set of processing operations to the signalprovided by sensor 318 to produce input signal 316 that can beappropriately interpreted by processor 312, such as performing A/Dconversion. In some embodiments, A/D conversion may be performed byprocessor 312. Pre-processor 320 may also perform any of the followingoperations on the signal provided by sensor 318: reshaping the signalfor transmission, multiplexing the signal, modulating the signal ontocarrier signals, compressing the signal, encoding the signal, andfiltering the signal. In some embodiments, pre-processor 320 may includea current-to-voltage converter (e.g., to convert a photocurrent into avoltage), an amplifier, a filter, and A/D converter, a de-multiplexer,any other suitable pre-processing components, or any combinationthereof.

In some embodiments, signal 316 may include PPG signals corresponding toone or more light frequencies, such as an IR PPG signal and a Red PPGsignal. In some embodiments, signal 316 may include signals measured atone or more sites on a subject's body, for example, a subject's finger,toe, ear, arm, or any other body site. In some embodiments, signal 316may include multiple types of signals (e.g., one or more of an ECGsignal, an EEG signal, an acoustic signal, an optical signal, a signalrepresenting a blood pressure, and a signal representing a heart rate).Signal 316 may be any suitable biosignal or any other suitable signal.

In some embodiments, signal 316 may be coupled to processor 312.Processor 312 may be any suitable software, firmware, hardware, orcombination thereof for processing signal 316. For example, processor312 may include one or more hardware processors (e.g., integratedcircuits), one or more software modules, computer-readable media such asmemory, firmware, or any combination thereof. Processor 312 may, forexample, be a computer or may be one or more chips (i.e., integratedcircuits). Processor 312 may, for example, include an assembly of analogelectronic components. Processor 312 may calculate physiologicalinformation. For example, processor 312 may compute one or more of apulse rate, respiration rate, blood pressure, or any other suitablephysiological parameter. Processor 312 may perform any suitable signalprocessing of signal 316 to filter signal 316, such as any suitableband-pass filtering, adaptive filtering, closed-loop filtering, anyother suitable filtering, and/or any combination thereof. Processor 312may also receive input signals from additional sources (not shown). Forexample, processor 312 may receive an input signal containinginformation about treatments provided to the subject. Additional inputsignals may be used by processor 312 in any of the calculations oroperations it performs in accordance with processing system 300.

In some embodiments, all or some of pre-processor 320, processor 312, orboth, may be referred to collectively as processing equipment. In someembodiments, any of the processing components and/or circuits, orportions thereof, of FIGS. 1-3 may be referred to collectively asprocessing equipment. For example, processing equipment may beconfigured to amplify, filter, sample and digitize input signal 316(e.g., using an analog to digital converter), and calculatephysiological information from the digitized signal. In someembodiments, all or some of the components of the processing equipmentmay referred to as a processing module.

Processor 312 may be coupled to one or more memory devices (not shown)or incorporate one or more memory devices such as any suitable volatilememory device (e.g., RAM, registers, etc.), non-volatile memory device(e.g., ROM, EPROM, magnetic storage device, optical storage device,flash memory, etc.), or both. The memory may be used by processor 312to, for example, store fiducial information or initializationinformation corresponding to physiological monitoring. In someembodiments, processor 312 may store physiological measurements orpreviously received data from signal 316 in a memory device for laterretrieval. In some embodiments, processor 312 may store calculatedvalues, such as a pulse rate, a blood pressure, a blood oxygensaturation, a fiducial point location or characteristic, aninitialization parameter, or any other calculated values, in a memorydevice for later retrieval.

Processor 312 may be coupled to output 314. Output 314 may be anysuitable output device such as one or more medical devices (e.g., amedical monitor that displays various physiological parameters, amedical alarm, or any other suitable medical device that either displaysphysiological parameters or uses the output of processor 312 as aninput), one or more display devices (e.g., monitor, PDA, mobile phone,any other suitable display device, or any combination thereof), one ormore audio devices, one or more memory devices (e.g., hard disk drive,flash memory, RAM, optical disk, any other suitable memory device, orany combination thereof), one or more printing devices, any othersuitable output device, or any combination thereof.

It will be understood that system 300 may be incorporated into system 10(FIGS. 1 and 2) in which, for example, input signal generator 310 may beimplemented as part of sensor unit 12 (of FIGS. 1 and 2) and monitor 14(of FIGS. 1 and 2) and processor 312 may be implemented as part ofmonitor 14 (FIGS. 1 and 2). In some embodiments, portions of system 300may be configured to be portable. For example, all or part of system 300may be embedded in a small, compact object carried with or attached tothe subject (e.g., a watch, other piece of jewelry, or a smart phone).In some embodiments, a wireless transceiver (not shown) may also beincluded in system 300 to enable wireless communication with othercomponents of system 10 (FIGS. 1 and 2). As such, system 10 (FIGS. 1 and2) may be part of a fully portable and continuous subject monitoringsolution. In some embodiments, a wireless transceiver (not shown) mayalso be included in system 300 to enable wireless communication withother components of system 10. For example, pre-processor 320 may outputsignal 316 over BLUETOOTH, 802.11, WiFi, WiMax, cable, satellite,Infrared, or any other suitable transmission scheme. In someembodiments, a wireless transmission scheme may be used between anycommunicating components of system 300. In some embodiments, system 300may include one or more communicatively coupled modules configured toperform particular tasks. In some embodiments, system 300 may beincluded as a module communicatively coupled to one or more othermodules.

Pre-processor 320 or processor 312 may determine rate based on aperiodicity within physiological signal 316 (e.g., a PPG signal) that isassociated with a subject's pulse rate using one or more processingtechniques. For ease of illustration, the following rate determinationtechniques will be described as performed by processor 312, but anysuitable processing device (e.g., pre-processor 320, microprocessor 48,any other suitable components of system 10 and/or system 300, or anycombination thereof) may be used to implement any of the techniquesdescribed herein.

Physiological information such as pulse rate may be determined based onsignals received from a physiological sensor. FIG. 4 is a flow diagram400 showing illustrative steps for determining a physiological rate.Flow diagram 400 discloses a process for determining initializationparameters (referred to herein as “Search Mode”), and then using theinitialization parameters to calculate a physiological rate andqualifying the calculated physiological rate prior to output (referredto herein as “Locked Mode”). In some embodiments, the physiological ratemay be a pulse rate associated with a subject.

The steps of flow diagram 400, and all subsequent flow diagrams of thisdisclosure, may be performed using the physiological monitoring system10 of FIGS. 1-2, system 300 of FIG. 3, any other suitable system, or anycombination thereof. For example, in some embodiments, the steps may beperformed by a particular central processing unit (CPU) of physiologicalmonitoring system 10 (e.g., including microprocessor 48, bus 50, and anyor all components coupled to bus 50). In a further example (not shown),physiological monitoring system 10 may be a modular system, includingone or more functional modules (i.e., software, hardware, or acombination of both) configured to perform particular tasks or portionsof tasks thereof. Any suitable arrangement of physiological monitoringsystem 10, any other suitable system, or any combination thereof, may beused in accordance with the present disclosure. For illustrativepurposes, the flow diagrams of the present disclosure will be discussedin reference to processing equipment, which may include physiologicalmonitoring system 10, system 300 of FIG. 3, any other suitable system,any suitable components thereof, or any combination thereof.

Step 402 may include processing equipment receiving at least onephysiological signal from a physiological sensor, memory, any othersuitable source, or any combination thereof. For example, referring tosystem 300 of FIG. 3, processor 312 may receive a physiological signalfrom input signal generator 310. Sensor 318 of input signal generator310 may be coupled to a subject, and may detect physiological activitysuch as, for example, RED and/or IR light attenuation by tissue, using aphotodetector. In some embodiments, physiological signals generated byinput signal generator 310 may be stored in memory (e.g., ROM 52 of FIG.2) after being pre-processed by pre-processor 320. In some such cases,step 402 may include recalling the signals from the memory for furtherprocessing. The portion of the physiological signal used for furtherprocessing may be referred to as the window of data.

The physiological signal of step 402 may be a photoplethysmograph (PPG)signal, which may include a sequence of pulse waves (e.g., having AC, orAC-DC coupled components) and may exhibit motion artifacts, noise fromambient light (e.g., 120 Hz lighting flicker from a 60 Hz grid power),electronic noise, system noise, any other suitable signal component, orany combination thereof. Step 402 may include receiving a particulartime interval or corresponding number of samples of the physiologicalsignal (e.g., a six second window of a sampled physiological signal). Insome embodiments, step 402 may include receiving a digitized, sampled,and pre-processed physiological signal.

Step 404 may include processing equipment (e.g., processor 312)determining whether initialization parameters have been set. In someembodiments, initialization parameters may include one or more algorithmsettings such as, for example, indexes for inputting into a look-uptable, filter settings, and/or templates (e.g., for cross-correlation,signal shape evaluation, or other calculations). In some embodiments,initialization parameters may include one or more settings of a filter(e.g., a band-pass filter) such as, for example, a high and lowfrequency cutoff value (e.g., a frequency range), a representativefrequency value, a set of one or more coefficients, any other suitableparameters, or any combination thereof. Physiological monitoring system10 may use initialization parameters to improve data processing (e.g.,reduce computational requirements, improve accuracy, reduce the effectsof noise) to extract physiological information in the presence of noise.This may be accomplished by effectively limiting the bandwidth of datato be analyzed, performing a rough calculation to estimate aphysiological rate or pulse, or otherwise mathematically manipulatingphysiological data.

While executing steps 406-412, the processing equipment (e.g., processor312) will be referred to as being in “Search Mode,” during which timethe processing equipment may search for, and qualify, a set of one ormore initialization parameters. Search Mode will also be described infurther detail during the discussion of FIGS. 5-71 of the presentdisclosure.

Step 406 may include processing equipment performing signal conditioningon the at least one received physiological signal of step 402. Signalconditioning may include filtering (e.g., low pass, high pass, bandpass, notch, or any other suitable filter), amplifying, performing anoperation on the received signal (e.g., taking a derivative, averaging),performing any other suitable signal conditioning, or any combinationthereof. For example, in some embodiments, step 406 may include removinga DC offset, low frequency components, or both, of the receivedphysiological signal. In a further example, step 406 may includesmoothing the received physiological signal (e.g., using a movingaverage or other smoothing technique).

Step 408 may include the processing equipment determining one or moreinitialization parameters. Step 408 may be used by the processingequipment to estimate one or more characteristics of a receivedphysiological signal such as, for example, physiological rates, periods,or likely ranges thereof. In some embodiments, initialization parametersmay include one or more settings of a filter such as, for example, ahigh and low frequency cutoff value of a band pass filter (e.g., afrequency range), a representative frequency value, a set of one or morecoefficients (e.g., weights for filter weighting), one or more settingsof a threshold calculation, any other suitable parameters, or anycombination thereof. The initialization parameters may be determinedbased on the received physiological signal of step 402. Someillustrative techniques of step 408, referred to herein as “SearchTechniques”, will be described in further detail during the discussionof FIGS. 5-37 of the present disclosure.

In some embodiments, step 408 may include performing calculations on thereceived physiological signal of step 402 (e.g., autocorrelations,cross-correlations, modulations, statistical computations), accessinginformation stored in memory (e.g., templates, look-up tables),executing algorithms, selecting particular initialization parametersfrom a collection of initialization parameters, any other suitableprocessing, or any combination thereof.

Step 410 may include the processing equipment qualifying the one or moredetermined initialization parameters of step 408, while step 412 mayinclude the processing equipment determining whether the qualificationof step 410 is sufficient. Step 410 may include calculating one or morequalification metrics indicative of an estimated quality of thedetermined initialization parameters. For example, a particularinitialization parameter may be determined at step 408, using anysuitable technique of the present disclosure. The particularinitialization parameters may be evaluated, and if it is determined thatthe parameters do not qualify at step 412 (e.g., exhibit a lowconfidence value), then the processing equipment may remain in “SearchMode” and repeat any or all of steps 400-412. Some illustrativetechniques of step 410, referred to as “Qualification Techniques”, willbe described in further detail herein during the discussion of FIGS.38-60 of the present disclosure.

While executing steps 414-428, the processing equipment will be referredto as being in “Locked Mode,” during which time the processing equipmentmay use a particular set of initialization parameters or previouslycalculated rates for further calculation and output of a physiologicalrate such as pulse rate. Locked Mode will also be described in furtherdetail during the discussion of FIGS. 72-80 of the present disclosure.

Step 414 may include the processing equipment performing signalconditioning on the at least one received physiological signal of step402. Signal conditioning may include filtering (e.g., low pass, highpass, band pass, notch, or any other suitable filter), amplifying,performing an operation on the received signal (e.g., taking aderivative, averaging), performing any other suitable signalconditioning, or any combination thereof. For example, in someembodiments, step 414 may include removing a DC offset, low frequencycomponents, or both, of the received physiological signal (e.g.,de-trending). In a further example, step 414 may include smoothing(e.g., using a moving average or other smoothing technique) the receivedphysiological signal.

Step 416 may include the processing equipment calculating aphysiological rate using the one or more initialization parameters ofstep 412 or step 404. The initialization parameters may be used at step416 to aid in calculating a physiological rate by filtering the receivedphysiological signal, providing an estimate of a physiological rate ofthe received signal, or otherwise aiding in calculating thephysiological rate. In some embodiments, the conditioned signal may beprocessed using an autocorrelation technique and the resultingautocorrelation output may be filtered based on one or moreinitialization parameters. The initialization parameters may also beused to extract a rate from the filtered autocorrelation signal. Forexample, a threshold may be calculated based on the initializationparameters and the rate may be calculated based on threshold crossings.Once an initial rate is determined, the subsequent calculations of ratecan be based on the previously calculated rates. Some illustrativetechniques of step 416, referred to herein as “Rate CalculationTechniques”, will be described in further detail during the discussionof FIGS. 72-80 of the present disclosure.

Step 418 may include the processing equipment performing Qualificationfor the calculated rate of step 416. Qualification may includecalculating a confidence value indicative of the likelihood that thecalculated rate is the “true” physiological rate. Step 420 may includedetermining whether the Qualification of step 418 satisfies particularcriteria.

If the calculated rate of step 416 is determined to be qualified at step420, then the processing equipment may filter the calculated rate, andmay output the filtered rate for display (e.g., on display 20 ofphysiological monitoring system 10) at step 422. For example, step 422may include low pass filtering of the calculated rate to limit the rateof change of the outputted rate to physiological ranges. In a furtherexample, step 422 may include applying an infinite impulse response(IIR) filter to the calculated rate of step 416. In some embodiments,step 422 may include storing the filtered rate values in memory such as,for example, RAM 54 or other suitable memory of physiological monitoringsystem 10.

If the calculated rate of step 416 is determined to be disqualified atstep 420, then the processing equipment may determine whether to resetthe one or more initialization parameters at step 424. If the processingequipment determines at step 424 that the one or more initializationparameters are to be reset, then the processing equipment may reset theone or more initialization parameters at step 426. Resetting the one ormore initialization parameters may include deleting one or more storedinitialization parameters from memory, and replacing them with otherparameters (e.g., use a default set of initialization parameters). Ifthe processing equipment determines at step 424 that the one or moreinitialization parameters are not to be reset, then the processingequipment may output the previous rate for display at step 428.

It will be understood that FIG. 4 is merely illustrative and thatvarious modifications can be made to FIG. 4 that are within the scope ofthe present disclosure. For example, while the rate calculation of FIG.416 is described as using one or more initialization parameters, theinitialization parameters may also be used or instead be used toinfluence the signal conditioning performed at step 414.

In some embodiments, initialization parameters may be used to 1) tune adynamic threshold (e.g., a CFAR threshold used at step 416) and 2) tunea bandpass (BP) filter (e.g., a BP filter used at step 414). The use ofone or more Search Techniques and Qualification Techniques to determineand qualify initialization parameters may aid in setting the BP filterthat may be used in Locked Mode. The BP filter may be applied before orafter an autocorrelation, but before a threshold is generated and/orapplied. The BP filter may, for example, have a width of the rate +/− apercentage or a fixed amount of BPM. Exemplary percentages may be+/−10%, 15%, 20%, 25%, and so on. Exemplary BPMs may be +/−10 BPM, 20BPM, 30 BPM, and so on, and the percentage and BPMs may be fixed orvariable. For example, at low rates the percentage may be higher andthen relatively lower as the rate increases. The percentage may varylinearly, non-linearly, based on a step function, based on any othersuitable function, or any combination thereof.

A relatively narrow, adjustable BP filter is good at rejecting noisewhen it tuned to the correct rate. However, if the BP filter is tunedincorrectly to noise, or if noise enters the range of the BP filter, thefilter may start to track the noise instead of the physiological rate,which would be undesired. The use of robust Qualification Techniquessuch as, for example, those disclosed herein, can prevent the BP filterfrom initially being tuned to noise. If at some point noise begins tocause the filter to deviate away from the physiological rate, theincorrect rates will be disqualified and prevent this from happening.Even if the filter begins to deviate from the physiological rate, thesystem will eventually depart from Locked Mode and return to Search Modeto relock back onto the physiological rate.

It will be understood that any of the techniques of Search Mode may beused with any techniques of Locked Mode, and vice-versa. In someembodiments, Search Mode need not be separate from Locked Mode. Forexample, system 300 may operate in a single mode using varioustechniques during operation. For example, Locked Mode may start by notusing a tuned BP filter, and using a fixed threshold instead of CFARthreshold. Once a rate is qualified, the adjustable BP filter and CFARmay be used. System 300 may use any suitable combination of Search Modetechniques and Locked Mode techniques to determine a physiological rate.In some embodiments, because the techniques of Search Mode may determinean indication of the physiological rate, any of the techniques of SearchMode may be used in Locked Mode to determine the physiological rate.

In some embodiments, Search Mode may include calculating anautocorrelation of a received physiological signal, and determining anumber of threshold crossings of the autocorrelation to estimate aphysiological rate or range thereof. FIG. 5 is a flow diagram 500(Search Technique 1) for determining one or more algorithm settings(i.e., one or more initialization parameters) based on the number ofthreshold crossings.

Step 502 may include processing equipment buffering a window of data,derived from a physiological signal. In some embodiments, the window mayinclude a particular time interval of the physiological signal (e.g.,the most recent six seconds of a processed physiological signal). Step502 may include pre-processing (e.g., using pre-processor 320) theoutput of a physiological sensor, and then storing a window of theprocessed data in any suitable memory or buffer (e.g., queue serialmodule 72 of FIG. 2), for further processing by the processingequipment. In some embodiments, the window of data may be recalled fromdata stored in memory (e.g., RAM 54 of FIG. 2 or any other suitablememory) for subsequent processing. In some embodiments, the window size(e.g., the number of samples or time interval of data to be buffered) ofdata is selected to capture multiple periods of oscillatoryphysiological activity. For example, a six second window of data, asshown illustratively by plot 550, may be used to capture about six pulsewaves of a photoplethysmograph of a nominal resting adult with a pulserate of approximately 1 Hz (i.e., 60 BPM). It will be understood thatany suitable window size may be used in accordance with the presentdisclosure, and six seconds is used for illustrative purposes.

Step 504 may include the processing equipment performing signalconditioning on the window of data of step 502. Signal conditioning mayinclude, for example, removing DC components, removing low frequencycomponents, removing high frequency components, or a combinationthereof, from the window of data. In some embodiments, a varyingbaseline may be removed from the window of data (i.e., de-trending) toconstrain the data average to zero or some other fixed value.

Step 506 may include the processing equipment performing anautocorrelation on the conditioned window of data of step 504. Shown inEq. 14:

$\begin{matrix}{{A_{xx}(j)} = {\sum\limits_{n = 0}^{N - 1}{x_{n}x_{n - j}}}} & (14)\end{matrix}$

is an illustrative expression for computing a discrete autocorrelationcoefficient A_(xx) for N samples x_(n) for a range of lag values indexedby j, respectively. The autocorrelation output may include a sequence ofpoints, and may be referred to as an autocorrelation sequence. The termautocorrelation, as used herein, shall also refer to a partialautocorrelation. For example, the term autocorrelation may be used todescribe a correlation between segments of a given window of data,whether or not the segments share any data points. Accordingly, as usedherein, the term autocorrelation may be used to describe a correlationbetween segments of a window of data sharing zero points, all points, orsome points. The term cross-correlation, as used herein, shall refer toa correlation between two sets of data points not included in the samewindow of data. In some embodiments, the first portion of data, thesecond portion of data, or both, may be padded with zeros (e.g., ateither or both ends of the portion) to equate the lengths of the firstand second portions to aid in performing an autocorrelation.

In some embodiments, the autocorrelation of step 506 may includecorrelating a first portion of the window of data with a second portionof the window of data. The first and second portions may be exclusive ofone another, may share one or more samples, or may be selected by anyother suitable partition of the window of data. For example, referencinga six second window of data 550, the most recent one second of data maybe correlated with the entire six seconds of data (as shown byautocorrelation setup 554, with lag j, which may originate at eitherendpoint). In a further example (not shown), the one second of data maybe correlated with the previous five seconds of data (exclusive of theone second of data). In some embodiments, there may be a time gapbetween the first and second portions. For example, the most recent onesecond of data may be correlated with previous data not immediatelypreceding the one second of data.

Step 508 may include the processing equipment determining a number ofthreshold crossings of the autocorrelation of step 506 for differentthreshold values. The autocorrelation may exhibit one or more peaks. Athreshold may include a fixed ordinate value (i.e., a horizontal lineacross a plot of the autocorrelation as shown in plot 556). Thethreshold may cross a number peaks (e.g., zero or more), as determinedby a calculating a suitable intersection of the threshold with asuitable portion of each peak that is crossed. For example, a crossingmay be defined as the intersection of the autocorrelation with thethreshold, at a point where the first derivative of the autocorrelationis positive (i.e., an up-slope). In a further example, a crossing may bedefined as the intersection of the autocorrelation with the threshold,at a point where the first derivative of the autocorrelation is negative(i.e., a down-slope). In a further example, a crossing may be defined asthe midpoint of two points of intersection of the autocorrelation withthe threshold where the first derivative of the autocorrelation isnegative and positive at the respective points (i.e., a point betweenup-slope and down-slope). Any suitable reference point may be used todefine a crossing. The threshold value may be varied, as shown by thedouble-tipped arrow of plot 556, causing a different number of peakcrossings to be calculated, as shown by plot 558. Plot 558 may includethe number of threshold crossings of the autocorrelation as a functionof threshold value.

In some embodiments, step 508 may be performed by initializing athreshold above the autocorrelation (i.e., a threshold value greaterthan any value of the autocorrelation), as shown in FIG. 6. FIG. 6 is aplot 600 of an illustrative autocorrelation 602 of a window of data,along with several thresholds 610, 620, 630, and 640, in accordance withsome embodiments of the present disclosure. The abscissa of plot 600 ispresented in units of sample number, while the ordinate is scaled inarbitrary units. Initially, referencing the origin of arrow 650,threshold 610 corresponds to an initial threshold value, having nointersections with the autocorrelation. As the threshold value is variedin the direction of arrow 650, the autocorrelation will cross thethreshold value. For example, there are four peak crossings forthreshold 620, while there are six peak crossings for threshold 630. Forthreshold 640, there are again zero peak crossings, similar to threshold610, because the threshold value is less than every value of theautocorrelation. Any suitable variation in threshold may be used inaccordance with the present disclosure (e.g., the threshold value may beinitialized at a value less than every value of the autocorrelation andincreased).

In some embodiments, the output of step 508 may include a dataset ofnumber of threshold crossings as a function of threshold value. Oneexample of illustrative output of step 508 is shown in FIG. 7. FIG. 7 isan illustrative plot 700 of the number of threshold crossings 702 of anautocorrelation as a function of threshold position, in accordance withsome embodiments of the present disclosure. The abscissa of plot 700corresponds to threshold position in arbitrary units, with zerocorresponding to a threshold position above the autocorrelation (i.e.,non-intersecting), and increasing abscissa values corresponding to lowerpositions of the threshold. The units of the ordinate of plot 700 arethe number of threshold crossings by the autocorrelation. Observing fromleft to right, it can be seen from plot 700 that the number of crossingsstarts at zero (i.e., threshold above the autocorrelation), increases asthreshold position lowers, plateaus at six crossings as shown byhighlight 704, increases over relatively shorter duration to seven andeight crossings as shown by highlight 706, and then decreases again tozero (i.e., threshold below the autocorrelation). The plateau indicatedby highlight 704 may be attributed to relatively pronounced peaks in theautocorrelation. The shorter duration excursions indicated by highlight706 may be attributed to noise or other relatively smaller features ofthe autocorrelation.

In some embodiments, the particular number of crossings with the longestduration in units of threshold position (i.e., plot 700 abscissa) may beprovide an estimate of the number of peaks in the autocorrelation. Forexample, referencing plot 700, the longest plateau appears at sixthreshold crossings, which may indicate that six peaks are present inthe autocorrelation. In some embodiments, the determination of six peaksmay provide an estimate or rough approximation of pulse rate, or a rangethereof (e.g., used to select settings of a band pass filter forprocessing the window of data). For example, six peaks in anautocorrelation of a six second window of data may indicate the pulserate is in a range of about 5/6 Hz to 7/6 Hz (i.e., 50-70 BPM) or about1 Hz (i.e., 60 BPM). Similarly, a determination of twelve peaks in anautocorrelation of a six second window of data may indicate that thepulse rate is in a range of about 11/6 Hz to 13/6 Hz (i.e., ˜110-130BPM) or about 2 Hz (i.e., 120 BPM).

Step 510 of flow diagram 500 may include the processing equipmentanalyzing the number of threshold crossings to determine one or morealgorithm settings. As the threshold value of step 508 is varied, thenumber of threshold crossings by the autocorrelation may vary, as shownby plot 558. In some embodiments, the analysis of step 510 may includeanalyzing the stability of the number of threshold crossings over two ormore threshold settings of multiple threshold settings. For example, theprocessing equipment may determine a plateau in the number of thresholdcrossings (e.g., as shown by highlight 704 of FIG. 7). In someembodiments, the analysis of step 510 may include analyzing more thanone autocorrelation (i.e., of different windows of data) to generate ahistogram of the number of crossings corresponding to a plateau for eachautocorrelation (as shown by plot 560, and in more detail in FIG. 8).The use of a histogram for analyzing the number of crossings formultiple autocorrelations may reduce the effects of noise, signalexcursions, or other sources of uncertainty in the number of peaks.

FIG. 8 is an illustrative histogram 800 of instances 802 of variousnumbers of threshold crossings, in accordance with some embodiments ofthe present disclosure. The abscissa of plot 800 corresponds to numberof crossings. Note that the “bins” of the abscissa of the histogram arenot necessarily bounded by integer values, but may be bounded by integervalues in some embodiments. The units of the ordinate of plot 800 areinstances of each number of crossings, as derived from multipleautocorrelations corresponding to multiple windows of data. Theinstances 802 of the illustrative histogram of plot 800 exhibit amaximum value at six crossings, indicating that six crossings is themost common number of crossings associated with an autocorrelation. Step510 of flow diagram 500 may include using this value of six associatedwith the maximum in the histogram to estimate or approximate a pulserate and/or pulse rate range. For example, a maximum value in instances802 at six crossings, calculated from multiple windows of data each sixseconds long, may roughly indicate a pulse rate in a range of about 5/6Hz to 7/6 Hz (i.e., ˜50-70 BPM) or about 1 Hz (i.e., 60 BPM).

It will be understood that noise and/or physiological characteristics ofpulses (e.g., dicrotic notches) may cause other bins in the histogram tohave large values and the processing of the threshold crossinginformation may take this into account. For example, a strong dicroticnotch may cause additional peaks to appear in the autocorrelation at thelocations of the valleys shown in FIG. 6. As a result, there may be morethan one stable region when the number of threshold crossings isplotted. Additional processing logic may be used to identify when thereare two stable regions, where one stable region occurs at approximatelydouble the number of crossings as the other stable region. The stableregion at the lower number of crossings may be selected and used toestimate or approximate a pulse rate and/or pulse rate range.

In some embodiments, Search Mode may include calculating anautocorrelation of a received physiological signal, and analyzing peakshapes of the autocorrelation to estimate a physiological rate or rangethereof. FIG. 9 is a flow diagram 900 (Search Technique 2) ofillustrative steps for determining one or more algorithm settings (i.e.,one or more initialization parameters) based on analyzing physiologicalpeaks, in accordance with some embodiments of the present disclosure.

Step 902 may include the processing equipment buffering a window ofdata, derived from a physiological signal. In some embodiments, thewindow may include a particular time interval (e.g., the most recent sixseconds of a processed physiological signal). Step 902 may includepre-processing (e.g., using pre-processor 320) the output of aphysiological sensor, and then storing a window of the processed data inany suitable memory or buffer (e.g., queue serial module 72 of FIG. 2),for further processing by the processing equipment. In some embodiments,the window of data may be recalled from data stored in RAM (e.g., RAM 54of FIG. 2) for subsequent processing. In some embodiments, the windowsize (e.g., the number of samples or time interval of data to bebuffered) of data is selected to capture multiple periods of oscillatoryphysiological activity. For example, a six second window, as shownillustratively by plot 950, may be used to capture about six pulse waveperiods of a photoplethysmograph of a nominal resting adult with a pulserate of approximately 1 Hz (i.e., 60 BPM). It will be understood thatany suitable window size may be used in accordance with the presentdisclosure, and six seconds is used for illustrative purposes. In someembodiments, the physiological signal may be an optical intensitysignal, and the window of data may be indicative of an optical intensitydetected by a suitable detector.

Step 904 may include the processing equipment performing signalconditioning on the window of data of step 902. Signal conditioning mayinclude, for example, removing DC components, removing low frequencycomponents, removing high frequency components, removing the mean,normalizing the standard deviation to one, performing any other suitablesignal conditioning, or any combination thereof. In some embodiments, avarying baseline may be removed from the window of data (i.e.,de-trending) to, for example, constrain the data average to zero or someother fixed value.

Step 906 may include the processing equipment performing anautocorrelation on the conditioned window of data of step 904. In someembodiments, the autocorrelation of step 906 may include correlating afirst portion of the window of data with a second portion of the windowof data, to generate an autocorrelation sequence. The first and secondportions may be exclusive of one another, may share one or more samples,or may be selected by any other suitable partition of the window ofdata. For example, referencing a six second window of data 950, the mostrecent one second of data may be correlated with the entire six secondsof data (as shown by autocorrelation setup 956, with lag j, which mayoriginate at either endpoint). In a further example (not shown), the onesecond of data may be correlated with the previous five seconds of data(exclusive of the one second of data). In some embodiments, there may bea time gap between the first and second portions. For example, the mostrecent one second of data may be correlated with previous data notimmediately preceding the one second of data. In some embodiments, thefirst portion of data, the second portion of data, or both, may bepadded with zeros to equate the lengths of the first and second portionsto aid in performing the autocorrelation of step 906.

Step 908 may include the processing equipment analyzing the shape ofpeaks in the autocorrelation to identify physiological peaks.Physiological peaks may refer to peaks corresponding to a physiologicalrate. The autocorrelation of step 906 may exhibit one or more peaks, asshown by the autocorrelation of plot 958. Step 908 may includedetermining metrics of each peak such as the width, amplitude, symmetry(e.g., symmetry about a vertical axis), full width at half maximum(FWHM), any other suitable peak metric, or any combination thereof.Peaks demonstrating particular characteristics based on the determinedmetrics may be identified as physiological peaks, as opposed to noise orartifact peaks. A candidate peak of the autocorrelation of plot 958 isshown in panel 960. Further detail regarding peak shape andidentification is provided in the discussion of FIG. 11 of thisdisclosure.

Step 910 may include the processing equipment analyzing the identifiedphysiological peak(s) of step 908 to determine one or more algorithmsettings. In some embodiments, step 910 may include estimating aphysiological rate (e.g., a pulse rate), or range thereof, based on apeak shape. For example, the width of a peak (e.g., as shown by thehorizontal double-tipped arrow of panel 960) may provide an indicationof a pulse rate. In a further example, when more than one peak isidentified at step 908, an average peak width may be calculated toprovide an indication of a pulse rate. In a further example, when morethan one peak is identified at step 908, a range of peak widths may becalculated to provide an indication of a range in pulse rate. In afurther example, a FWHM value of a peak identified at step 908 may becalculated and used with a predetermined look-up table to determine oneor more corresponding algorithm settings.

FIG. 10 is a plot 1000 of an illustrative filtered PPG signal 1002, inaccordance with some embodiments of the present disclosure. The abscissaof plot 1000 is presented in units of sample number, while the ordinateis scaled in arbitrary units, with zero notated. In the illustratedembodiment, PPG signal 1002 is a window of six seconds of sampledintensity data (i.e., at a sampling rate of roughly 57 Hz) that wasprocessed with a derivative filter. The most recent data corresponds tothe right side of plot 1000, while more historical data corresponds tothe left side of plot 1000. The oscillatory behavior of PPG signal 1002,due to pulse rate, is easily observed by the six negative peaks spacedabout 1 second apart. An autocorrelation may be performed on PPG signal1002, using any suitable partition of PPG signal 1002 and any suitablenumerical technique. For example, the most recent one second of PPGsignal 1002 may be correlated with the entire six second window to givea roughly seven second autocorrelation function, as shown in FIG. 11.FIG. 11 is a plot 1100 of an autocorrelation 1102 of PPG signal 1002 ofFIG. 10, with several peak shapes notated by dashed boxes 1110, 1120,and 1130, in accordance with some embodiments of the present disclosure.The abscissa of plot 1100 is presented in units of autocorrelation lagposition, while the ordinate is scaled in arbitrary units, with zeronotated.

Several peaks have been notated by dashed boxes in FIG. 11. Box 1110corresponds to a relatively small peak with respect to amplitude andwidth. This peak also exhibits poor symmetry, which indicates that thispeak may be “riding” along a larger peak. In general, such a peak wouldnot be identified as a physiological peak by the processing equipment,and may be a correlation artifact. Similarly, box 1130 corresponds toanother relatively small peak with respect to amplitude and width,albeit exhibiting relatively more symmetry than the peak in box 1110. Ingeneral, the peak in box 1130 would also not be identified as aphysiological peak by the processing equipment. Box 1120 corresponds toa relatively large peak with respect to amplitude and width, withsufficiently symmetrical character. In general, this peak would beidentified as a physiological peak by the processing equipment. It willbe understood that the identification of physiological peaks may bebased on a comparison of one or peak metrics (e.g., amplitude, width,symmetry, FWHM, or other any other suitable metric, or any combinationthereof) to threshold values, which may vary. For example, the amplitudeof a peak (e.g., the height of a dashed box of FIG. 11) may be comparedwith a threshold value, and if the amplitude exceeds the thresholdvalue, the peak may be determined to be a physiological peak. In afurther example, the width of a peak (e.g., the width of a dashed box ofFIG. 11) may be compared with a threshold value, and if the widthexceeds the threshold value, the peak may be determined to be aphysiological peak. In a further example, the amplitude to width ratioof a peak (e.g., the aspect ratio of a dashed box of FIG. 11) may becompared with a threshold value, and if the ratio exceeds the thresholdvalue, the peak may be determined to be a physiological peak. In someembodiments, more than one threshold value may be used to categorize apeak. For example, a peak may be determined to be of physiologicalorigin if both the amplitude and width exceed particular thresholdvalues. In some embodiments, a peak identified as a physiological peakunder a particular set of circumstances or settings need not beidentified as a physiological peak under a different set ofcircumstances or settings.

FIG. 12 is a plot 1200 of an illustrative filtered PPG signal 1202,relatively noisier than PPG signal 1002 of FIG. 10, in accordance withsome embodiments of the present disclosure. The abscissa of plot 1200 ispresented in units of sample number, while the ordinate is scaled inarbitrary units, with zero notated. In the illustrated embodiment, PPGsignal 1202 is a window of six seconds of sampled intensity data (i.e.,at a sampling rate of roughly 57 Hz) that was processed with aderivative filter. The most recent data corresponds to the right side ofplot 1200, while more historical data corresponds to the left side ofplot 1200. The oscillatory behavior of PPG signal 1202, due to pulserate, is of higher frequency than that of PPG signal 1002, with largeartifacts due to motion or other lower frequency components (e.g.,characteristic of a neonate). An autocorrelation may be performed on PPGsignal 1202, using any suitable partition of PPG signal and any suitablenumerical technique. For example, the most recent one second of PPGsignal 1002 may be correlated with the entire six second window to givea roughly seven second autocorrelation function, as shown in FIG. 13.FIG. 13 is a plot 1300 of an illustrative autocorrelation 1302 of PPGsignal 1202 of FIG. 12, with several peak shapes notated by dashed boxes1310 and 1320, in accordance with some embodiments of the presentdisclosure. The abscissa of plot 1300 is presented in units ofautocorrelation lag, while the ordinate is scaled in arbitrary units,with zero notated.

The superposition of low frequency components of relatively largeamplitude and a physiological pulse component of the same or smalleramplitude may present challenges in determining the pulse rate. Box 1310corresponds to a peak exhibiting poor symmetry, having a steep baselinecharacteristic of lower frequency activity. Although the peakcorresponding to box 1310 is due to a physiological pulse, the shape ofthe peak may present challenges during shape analysis. Additionally, box1320 is associated with a peak exhibiting relatively low amplitude.Again, although the peak corresponding to box 1320 is due to aphysiological pulse, the shape of the peak may present challenges duringshape analysis. Under some circumstances, such as performingcalculations on noisy PPG signal 1202, techniques other than, or inaddition to, those described in flow diagram 900 may be preferred. Insome embodiments, the processing equipment may be trained (e.g., byusing a neural network) or otherwise programmed (e.g., with subjectspecific peak shapes and thresholds) to recognize peak shapes of noisyphysiological data, as shown in FIG. 13. In addition, peaks may beanalyzed in combination with other peaks or based on characteristics ofother peaks. For example, metrics and/or statistics may be computed onall or a subset of the peaks identified in FIG. 13. For example, thepeak widths may be analyzed to determine an average or median peak widthand/or to compute a histogram of peak widths. A consistent or relativelyconsistent peak width among the peaks may indicate physiological pulseinformation even though other aspects of the peaks (e.g., symmetry) maybe undesirable or lack consistency. The information from multiple peaksmay then be used to determine the settings of the algorithm. Any of thetechniques described herein may be used in concert with, or in lieu of,the illustrative techniques of flow diagram 900 during Search Mode.

In some embodiments, Search Mode may include performing cosine and sinemodulation of a received physiological signal, and analyzing a phasedifference of the modulated signals, to estimate a physiological rate orrange thereof. FIG. 14 is a flow diagram 1400 (Search Technique 3) ofillustrative steps for determining one or more algorithm settings (i.e.,one or more initialization parameters) based on a phase between aphysiological signal and modulated signals, in accordance with someembodiments of the present disclosure.

Step 1402 may include processing equipment performing signalconditioning on a physiological signal, or window thereof. Signalconditioning may include removing DC components, low frequencycomponents, or both, from the window of data (e.g., by high-pass orband-pass filtering). In some embodiments, a varying baseline may beremoved from the window of data (i.e., de-trending) to constrain thedata average to zero. In some embodiments step 1402 may includecalculating an ensemble average window of data of multiple windows ofdata. In some embodiments, step 1402 may include smoothing thephysiological signal. For example, a moving average may be calculatedand outputted as the conditioned signal.

Step 1404 may include the processing equipment performing a firstmodulation such as, for example, a cosine modulation as shown by Eq.15a:

f _(c)(j)=f(j)cos(ωt _(j))  (15a)

in which f (j) is the conditioned signal at sample j, ω is acharacteristic frequency (e.g., in units of radians/s, and sometimesreferred to as angular velocity), t_(j) is a time associated with thesample j, and f_(c)(j) is the cosine modulated signal. The cosinemodulation may include multiplying the conditioned physiological signalby a cosine function of time, having some frequency ω. In someembodiments, step 1404 may include performing the cosine modulationusing multiple ω values. The values of ω may be bounded within aphysiological range, such as about 0.33-5 Hz, corresponding to about20-300 BPM. In some embodiments, processing equipment may determine oneor more ω values that provide a substantially stable phase (e.g., aroughly constant phase).

Step 1406 may include the processing equipment performing secondmodulation such as, for example, a sine modulation as shown by Eq. 15b:

f _(s)(j)=f(j)sin(ωt _(j))  (15b)

in which f(j) is the conditioned signal at sample j, ω is acharacteristic frequency, t_(j) is a time associated with the sample j,and f_(s)(j) is the sine modulated signal. The sine modulation mayinclude multiplying the conditioned physiological signal by a sinefunction of time, having some frequency ω. In some embodiments, step1406 may include performing the sine modulation using multiple ω values.The one or more values of ω may be the same as those of step 1404. Itwill be understood that while the first and second modulation signalsare discussed herein illustratively in the context of cosine and sinemodulations, any suitable modulation functions may be used to generate afirst and a second modulated signals. Additionally, the modulationfunctions may have any suitable periodic character, including functionssuch as, for example, a sawtooth wave, a series of concatenated peakshapes, or other suitable functions.

Step 1408 may include the processing equipment filtering the modulatedsignals of steps 1404 and 1406. Step 1408 may include applying a lowpass filter to the modulated signals of steps 1404 and 1406. In someembodiments, the filter used in step 1408 may depend on the value of ω,reducing the presence of higher frequency activity in the modulatedsignals. In some embodiments, the filter used in step 1408 may be basedon an expected physiological range (e.g., low-pass filtering to reducecomponents above 5 Hz/300 BPM). For example, the processing equipmentmay apply a heterodyne technique, in which the product of two originalperiodic signals (i.e., the physiological signal and a modulationsignal) may be expressed as the sum of two periodic functions havingrespective frequencies equal to the difference and the sum of thefrequencies of the two original periodic signals.

Step 1410 may include the processing equipment determining a phasebetween the modulated signals for the one or more values of ω used insteps 1404 and 1406. In some embodiments, the processing equipment mayinclude, or communicate with, a phase detector (e.g., software,hardware, or both) which may detect a phase between the cosine and sinemodulated signals. In some embodiments, a phase may be calculated ateach sample point of the modulated signals, generating a phase signal.For example, referencing the heterodyne technique, shown below are Eqs.16a and 16b:

$\begin{matrix}\begin{matrix}{{f_{c}(j)} = {{\cos \left( {{\omega \; t_{j}} + \phi} \right)}{\cos \left( {\omega \; t_{j\;}} \right)}}} \\{= \left. \frac{\left( {{\cos (\phi)} + {\cos \left( {{2\omega \; t_{j}} + \phi} \right)}} \right)}{2}\rightarrow{\frac{1}{2}\cos \; (\phi)} \right.} \\{= I}\end{matrix} & \left( {16a} \right) \\\begin{matrix}{{f_{s}(j)} = {{\cos \left( {{\omega \; t_{j}} + \phi} \right)}{\sin \left( {\omega \; t_{j\;}} \right)}}} \\{= \left. \frac{\left( {{\sin \left( {{2\omega \; t_{j}} + \phi} \right)} - {\sin (\phi)}} \right)}{2}\rightarrow{\frac{- 1}{2}\sin \; (\phi)} \right.} \\{= Q}\end{matrix} & \left( {16b} \right) \\{\phi = {\arctan \left( {- \frac{Q}{I}} \right)}} & \left( {16c} \right)\end{matrix}$

in which modulated signals f_(c)(j) and f_(s)(j) are derived from anoriginal signal f(j)=cos(ωt_(j)+φ), which is used as a relatively simpleexample for illustration. The rightward pointing arrows represent lowpass filtering of the modulated signals, which removes the relativelyhigher frequency component of the modulated signals. Shown in Eq. 16c isan illustrative expression for determining the phase between theoriginal signal (e.g., a physiological signal) and the modulationsignals (e.g., the sine and cosine functions). The processing equipmentmay determine the phase of a conditioned physiological signal relativeto modulation signals by using Eqs. 16a-16c, where the conditionedphysiological signal is substituted for f(j).

Step 1412 may include the processing equipment analyzing a phase signalbased on the first modulated intensity signal and the second modulatedintensity signal to determine one or more algorithm settings. In someembodiments, step 1412 may include selecting the ω value exhibiting themost constant phase over the domain (e.g., about 350 samples asillustrated in FIG. 17) as determined in step 1410. For example, in someembodiments, the processing equipment may calculate a mean value of thephase signal for each ω value and then calculate the root-mean-squaredifference between each phase signal and corresponding mean. If aparticular ω value is too high or too low relative to a physiologicalfrequency (e.g., a pulse rate) of the physiological signal, the phasesignal may be observed to change over the domain (e.g., time or samplenumber). Values of ω closer to the physiological frequency are expectedto exhibit phases that remain roughly constant over the domain for asubject that does not exhibit a temporal change in rate. For example, anequation such as Eq. 17:

$\begin{matrix}{R_{\omega} = {\frac{1}{N}\sqrt{\sum\limits_{n = 0}^{N - 1}\left( {x_{n,\omega} - {\overset{\_}{x}}_{\omega}} \right)^{2}}}} & (17)\end{matrix}$

may be used to quantify the deviation of the phase signal from aconstant value. In Eq. 17, x_(n,ω) is the nth sample of N samples, x_(ω) is the phase mean value, and R_(ω) is the RMS deviation.

In a further example, the difference between the maximum and minimumvalues of the phase signal may provide an indication of the constancy ofthe phase signal. Any suitable metric may be used to determine the ωvalue that corresponds to the most constant phase between thephysiological signal and the modulation signals. The selected ω valuemay be used to initialize parameters of the algorithm, including, forexample, one or more settings of a band pass filter such a high and lowfrequency cutoff value (e.g., a frequency range), a representativefrequency value, a set of one or more coefficients, any other suitableparameters, or any combination thereof.

FIG. 15 is a plot 1500 of an illustrative filtered photoplethysmographsignal 1502, in accordance with some embodiments of the presentdisclosure. The abscissa of plot 1500 is presented in units of samplenumber, while the ordinate is scaled in arbitrary units.

FIG. 16 is a plot 1600 of a physiological signal modulated by both sine(i.e., modulated signal 1602) and cosine (i.e., modulated signal 1604)functions, in accordance with some embodiments of the presentdisclosure. The abscissa of plot 1600 is presented in units of samplenumber, while the ordinate is scaled in arbitrary units. Modulatedsignals 1602 and 1604 may be generated, for example, by performing steps1404 and 1406 of flow diagram 1400 of FIG. 14, respectively. The phasebetween the physiological signal and the modulated signals 1602 and 1604is observed to be roughly constant between about 110-120 samples, acrossthe entire domain of plot 1600 of about 350 samples.

FIG. 17 is a plot 1700 of the phase signals 1702, 1704, and 1706 betweenthe physiological signal and the modulation signals for three differentω values, in accordance with some embodiments of the present disclosure.The abscissa of plot 1700 is presented in units of sample number, whilethe ordinate is scaled in arbitrary units. Phase signals 1702, 1704 and1706 may be generated, for example, by performing step 1410 of flowdiagram 1400 of FIG. 14. Phase signals 1704 and 1702 correspond to ωvalues that are either too high or too low relative to a physiologicalfrequency (e.g., a pulse rate) of the physiological signal from whichthey were derived. This is exhibited by the significant changes in phasesignal over the domain of plot 1700. Note that the sharp verticalchanges in phase signals 1702 and 1704 occur when the phase exceeds π or−π rad, and the value is reset to between π and −π rad. Phase signal1706 corresponds to a ω value that is closer to the physiologicalfrequency relative to the ω values associated with phase signals 1702and 1704. This is exhibited by the roughly constant phase over theentire domain of plot 1700. Any suitable metric, such as those disclosedabove in the discussion of step 1412 of flow diagram 1400, may be usedto determine the sufficiency of the constant character of a phase suchas phase signal 1706.

In some embodiments, Search Mode may include performing anautocorrelation of a window of data and a cross-correlation with apre-determined cross-correlation waveform, to estimate a physiologicalrate or range thereof. FIG. 18 is a flow diagram 1800 (Search Technique4) of illustrative steps for determining one or more algorithm settings(i.e., one or more initialization parameters) based on across-correlation of a signal with a cross-correlation waveform, inaccordance with some embodiments of the present disclosure.

Step 1802 may include processing equipment buffering a window of data,derived from a physiological signal. In some embodiments, the window mayinclude a particular time interval (e.g., the most recent six seconds ofa processed physiological signal). Step 1802 may include pre-processing(e.g., using pre-processor 320) the output of a physiological sensor,and then storing a window of the processed data in any suitable memoryor buffer (e.g., queue serial module 72 of FIG. 2), for furtherprocessing by the processing equipment. In some embodiments, the windowof data may be recalled from data stored in memory (e.g., RAM 54 of FIG.2 or other suitable memory) for subsequent processing. In someembodiments, the window size (e.g., the number of samples or timeinterval of data to be buffered) of data is selected to capture multipleperiods of oscillatory physiological activity. For example, a six secondwindow may be used to capture about six pulse wave of aphotoplethysmograph of a nominal resting adult with a pulse rate ofapproximately 1 Hz (i.e., 60 BPM). It will be understood that anysuitable window size may be used in accordance with the presentdisclosure, and six seconds is used for illustrative purposes.

Step 1804 may include the processing equipment performing signalconditioning on the window of data of step 1802. Signal conditioning mayinclude, for example, removing DC components, removing low frequencycomponents, removing high frequency components, removing the mean,normalizing the standard deviation to one, performing any other suitablesignal conditioning, or any combination thereof. In some embodiments, avarying baseline may be removed from the window of data (i.e.,de-trending) to, for example, constrain the data average to zero or someother fixed value.

Step 1806 may include the processing equipment performing anautocorrelation on the conditioned window of data of step 1804. In someembodiments, the autocorrelation of step 1806 may include correlating afirst portion of the window of data with a second portion of the windowof data. The first and second portions may be exclusive of one another,may share one or more samples, or may be selected by any other suitablepartition of the window of data. For example, referencing a six secondwindow of data, the most recent one second of data may be correlatedwith the entire six seconds of data (as shown by autocorrelation setup1850, with lag j, which may originate at either endpoint, andautocorrelation output 1852). In a further example (not shown), the onesecond of data may be correlated with the previous five seconds of data(exclusive of the one second of data). In some embodiments, there may bea time gap between the first and second portions. For example, the mostrecent one second of data may be correlated with previous data notimmediately preceding the one second of data.

In some embodiments, step 1808 may include the processing equipmentperforming a cross-correlation of the autocorrelation of step 1806 withall or part of a cross-correlation waveform. In some embodiments, step1808 may include the processing equipment performing a cross-correlationof the conditioned physiological signal of step 1804 with across-correlation waveform, and step 1806 need not be performed. Thefollowing discussion, and FIG. 18, will reference using theautocorrelation of step 1806 for illustration, although the sametechniques will apply if step 1806 is omitted. The cross-correlationwaveform may include multiple segments, each having different frequencycomponents. For example, the cross-correlation waveform may include aconcatenation of segments, each including a waveform of a particularcharacteristic frequency. Panel 1854 shows a portion of an illustrativecross-correlation waveform, in accordance with some embodiments of thepresent disclosure. Further detail regarding generation of, andproperties of, the cross-correlation waveform is provided below in thediscussion of FIG. 19 and FIG. 20, for example. The output of step 1808may be a cross-correlation, exhibiting segments approximatelycorresponding to the segments of the cross-correlation waveform, asshown illustratively by panel 1856.

Step 1810 may include the processing equipment analyzing thecross-correlation output of step 1808 to determine one or more algorithmsettings. In some embodiments, step 1810 may include determining amaximum in the cross-correlation, and identifying a segment of thecross-correlation waveform corresponding to the maximum. In someembodiments, step 1810 may include identifying a pattern in thecross-correlation. For example, panel 1856 shows a cross-correlationwith one particular segment have a maximum value. The maximum value islocated in the center of the segment, with roughly linear fall-offs inamplitude to either side within the segment (i.e., sawtooth ortriangular type amplitude variation). This pattern, or other suitablepatterns, may be identified by the processing equipment. Panel 1858shows an illustrative upper envelope for the absolute value of across-correlation output. In some embodiments, characteristics of anupper envelope may be calculated, compared with threshold values, orotherwise analyzed to identify a physiological peak.

FIG. 19 is a flow diagram 1900 of illustrative steps for generating across-correlation waveform, in accordance with some embodiments of thepresent disclosure. It will be understood that any of the illustrativesteps of flow diagram 1900 may be optionally performed, and accordinglysome of the illustrative steps of flow diagram 1900 need not beperformed.

Step 1902 may include the processing equipment, or other suitableprocessing equipment, generating or selecting one or more basewaveforms. A base waveform will refer to a single period of a wave orpulse of any suitable type, although the base waveform may includehigher frequency components relative to the frequency componentcorresponding to the single period (e.g., a single period of a basewaveform may exhibit oscillatory behavior of smaller period). A basewaveform may be a mathematical function, one or more pulse waves of asubject's PPG, any other suitable waveform, or any combination thereof.For example, in some embodiments, a base waveform may be a sine wave,cosine wave, triangular wave, square wave, wavelet, any other suitablemathematical function, any portions thereof, or any combination thereof.In a further example, in some embodiments, a base waveform may be aprocessed PPG signal (e.g., filtered, averaged, smoothed or otherwiseprocessed), a component of a PPG (e.g., one or more scales of awavelet-transformed PPG signal), any other suitable physiologicalsignal, any portions thereof, or any combination thereof.

Step 1904 may include the processing equipment, or other suitableprocessing equipment, expanding or compressing the base waveform of step1902 to adjust the period, and concatenation two or more of the basewaveforms to form a segment. For example, a six second segment mayinclude six concatenated base waveforms each having a period of onesecond. A different six second segment may include twelve concatenatedbase waveforms that have been each compressed to a period of a halfsecond. In some embodiments, segments may include the same or differenttypes of base waveforms, having any suitable period. In someembodiments, step 1904 need not be performed. For example, one or morepre-generated segments may be stored, and no expansion, compression, orconcatenation need be required at step 1904 to form a segment.

Step 1906 may include the processing equipment generating multiplesegments (e.g., as described in step 1904), each having a differentcharacteristic (e.g., period of the base waveform). The multiplesegments may be generated sequentially, or in parallel, and may eachinclude any suitable type of base waveform. In some embodiments, step1906 need not be performed each time a cross-correlation waveform isgenerated. For example, one or more segments may be generated and storedfor later use, and accordingly, step 1906 need not be performed again atthe later time.

Step 1908 may include the processing equipment adding dithering to oneor more of the segments of step 1906. Dithering may include addingvariation to the period of base waveforms within a segment. For example,a particular segment may originally include six concatenated, identicalbase waveforms, each having a period of one second. Dithering may beadded to the particular segment by adjusting the period of the leftmostbase waveform to 0.9 seconds and adjusting the period of the rightmostbase waveform to 1.1 seconds. In a further example, dithering may beapplied continuously across a segment, generating a chirp-like segment.Any suitable technique for adding dithering to a segment may be used, inaccordance with the present disclosure. In some embodiments, step 1908need not be performed. In some embodiments, the processing equipment mayperform step 1908 as part of performing step 1904.

Step 1910 may include the processing equipment adjusting the amplitudeof one or more segments. In some embodiments, the amplitude of a segmentmay be adjusted based on the period of the base waveforms included inthe segment. In some embodiments, step 1910 may be performed as part ofthe base waveform generation of step 1902. In some embodiments, step1910 may be performed as part of the segment generation of step 1906. Insome embodiments, step 1910 need not be performed.

Step 1912 may include the processing equipment concatenating thesegments of step 1910 together. Step 1912 may include positioning themultiple segments end to end in a linear arrangement. In someembodiments the linear arrangement may be organized by segmentperiodicity. For example, segments may be arranged from lowest tohighest periodicity, or from highest to lowest periodicity. Theconcatenated segments will be referred to as a cross-correlationwaveform. In some embodiments, a cross-correlation waveform may includeconcatenated segments with padding (e.g., inserted zeros) between thesegments to reduce higher frequency components near the segmentboundaries. For example, padding segments of zeros, equal in length(i.e., time interval, number of samples) to the waveform segments, maybe inserted between each pair of adjacent segments, to minimize edgeeffects of the segment boundaries. In some embodiments, across-correlation waveform may include concatenated segments, which mayeach be scaled with a window function (e.g., at step 1910), such thateach segment decays to zero near the segment's boundaries. In someembodiments, a cross-correlation waveform may include concatenatedsegments with dithering (e.g., at step 1908) at the boundaries ofsegments to reduce higher frequency components near the segmentboundaries (e.g., due to abrupt changes in characteristic frequency). Insome embodiments, the cross-correlation waveform may include at leastone “chirp” type segment, which may include a gradual (i.e., linear)variation in frequency over the segment's domain. Any suitable techniquemay be used for generating the cross-correlation waveform from one ormore segments, in accordance with the present disclosure.

Step 1914 may include the processing equipment filtering theconcatenated segments of step 1912. In some embodiments, the processingequipment may apply a low-pass filter, band-pass filter, notch filter,any other suitable filter, or any combination thereof to theconcatenated segments to form the cross-correlation waveform. Forexample, the processing equipment may apply a low-pass filter to reduceand/or eliminate high frequency components (e.g., associated withsegment boundaries). In a further example, the cutoff frequency of thelow-pas filter may be based on initialization parameters. In someembodiments, step 1914 need not be performed, and the concatenatedsegments of step 1912 may be referred to as the cross-correlationwaveform.

FIG. 20 is a plot 2000 of an illustrative cross-correlation waveform2002, in accordance with some embodiments of the present disclosure. Theabscissa of plot 2000 is presented in units of cross-correlationwaveform sample number, while the ordinate is scaled in arbitrary units.Cross-correlation waveform 2002 includes multiple segments, each segmentincluding a waveform having a particular characteristic frequency.Accordingly, cross-correlation waveform 2002 has varying frequencycharacter, which may be used for comparison with a window of data, orautocorrelation derived thereof. In some embodiments, across-correlation waveform may include concatenated segments, eachhaving a particular characteristic frequency. In the illustratedembodiment of FIG. 20, the characteristic period of the segmentsincreases from left to right.

FIG. 21 is a plot 2100 of an illustrative window of data 2102 of aphysiological signal, in accordance with some embodiments of the presentdisclosure. The abscissa of plot 2100 is presented in units of samplenumber, while the ordinate is scaled in arbitrary units. In theillustrated embodiment, PPG signal 2102 is a window of six seconds ofsampled intensity data (i.e., at a sampling rate of roughly 57 Hz) thatwas processed with a derivative filter. The oscillatory behavior of PPGsignal 2102, due to pulse rate, is easily observed by the six negativepeaks spaced about one second apart. An autocorrelation may be performedon PPG signal 2102, using any suitable partition of PPG signal and anysuitable numerical technique.

FIG. 22 is a plot 2200 of an illustrative cross-correlation 2202 of anautocorrelation of a window of data with a cross-correlation waveform,in accordance with some embodiments of the present disclosure. Theabscissa of plot 2200 is presented in units of cross-correlation lag,while the ordinate is scaled in arbitrary units. Region 2204 ofcross-correlation 2202 highlights a particular portion of thecross-correlation having a relatively large amplitude, and pyramidalamplitude variation. The amplitude and shape of region 2204 may indicatea match or similarity in characteristic period between a particularsegment and a window of data.

FIG. 23 is a flow diagram 2300 of illustrative steps for selecting asegment of a cross-correlation waveform based on envelope analysis, inaccordance with some embodiments of the present disclosure.

Step 2302 may include processing equipment calculating the absolutevalue of a cross-correlation output. The cross-correlation output may begenerated by, for example, performing suitable steps of flow diagram1800 of FIG. 18. Calculation of the absolute value may aid indetermining characteristics of the cross-correlation output. In someembodiments, the cross-correlation output may be squared to ensure allpositive values for further analysis. Any suitable mathematicaltechnique may be used to condition the cross-correlation output.

Step 2304 may include the processing equipment generating an upperenvelope based on the cross-correlation output, or output signal derivedthereof (e.g., the absolute value of the cross-correlation output). Theupper envelope may be an outline of the cross-correlation amplitudes,providing a convenient curve for further processing. In someembodiments, the upper envelope may be generated using a mathematicalformalism such as, for example, a linear or spline fit through thecross-correlation data points. In some embodiments, the upper envelopemay be fitted through a representative point of each segment of thecross-correlation output. For example, the upper envelope may be fittedthrough points located at (x_(s),y_(s)), in which x_(s), is a midpointin the domain of each segment and y_(s) is an average amplitude in thesegment. Any suitable technique may be used to generate an upperenvelope of the cross-correlation output, or output signals derivedthereof.

Step 2306 may include the processing equipment analyzing the envelope ofstep 2304 to select a desired segment that corresponds to the window ofdata used for the cross-correlation. In some embodiments, step 2306 mayinclude locating one or more peaks in the envelope. In some embodiments,step 2306 may include analyzing a peak in the envelope to determinewhether the peak corresponds to a physiological pulse. Peak analysis mayinclude calculating a peak height, peak width (e.g., using any suitablecalculation such as FWHM), peak symmetry (e.g., skewness), peakbaseline, peak isolation (e.g., peak center locations relative towidths), peak up-slopes and down-slopes (e.g., maximum and minimumderivatives), peak aspect ratio (e.g., height to width ratio), any othersuitable peak characteristic, or any combination thereof. In someembodiments, step 2306 may include comparing one or more peakcharacteristics with a threshold value to determine whether to selectthe peak. For example, the processing equipment may locate the peak withthe largest amplitude and calculate one or more characteristics forcomparison with a threshold. If the peak is determined to not correspondto a physiological pulse based on the comparison, the processingequipment may locate another peak for analysis. The discussion of FIG.24 provides further detail and illustration of peak characteristics.

FIG. 24 is a plot 2400 of an illustrative cross-correlation output 2402(with absolute value having already been taken of the output) and upperenvelope 2410 (shown by the dotted line), in accordance with someembodiments of the present disclosure. The abscissa of plot 2400 ispresented in units of cross-correlation lag, by segment, while theordinate is scaled in arbitrary units, with zero baseline.Cross-correlation output 2402 includes fifty segments, corresponding tofifty segments in the cross-correlation waveform used to generate thecross-correlation output 2402. Each of the fifty segments ofcross-correlation output 2402 includes multiple data pointscorresponding to particular time lags in the cross-correlation betweenthe cross-correlation waveform and the window of data (orautocorrelation derived thereof).

Upper envelope 2410 includes three major peaks; peak 2404, peak 2406,and peak 2408. Peaks 2406 and 2404 have similar aspect ratios, while theheight of peak 2406 is roughly twice that of peak 2404. Peak 2408 isobservably wider than either peak 2404 or peak 2406, with a heightintermediate to peak 2404 and peak 2406. In some embodiments, theprocessing equipment may analyze signals such as cross-correlationoutput 2402 to determine which, if any, peaks may correspond to aphysiological rate.

In an illustrative example, processor 312 may determine that peak 2408does not correspond to a physiological pulse because the aspect ratio ofpeak 2408 is too near unity (i.e., the height of peak 2408 is too smallrelative to the FWHM). Processor 312 may determine that peak 2406 has alarger height than peak 2404, and accordingly may initially analyze peak2406. Under some circumstances, processor 312 may determine that peak2406 corresponds to a physiological rate, and select the segment of thecross-correlation waveform that corresponds to maximum of peak 2406. Insome embodiments, when processor 312 has selected a desired peak,further peaks need not be analyzed. Under some circumstances, peak 2408may be designated as a noise peak, and processor 312 may determine thatthe presence of peak 2408 encroaching near peak 2406 may warrantsanother window of data to be analyzed. Similarly, under somecircumstances, processor need not require a further window of data, andmay select peak 2406.

FIG. 25 is a flow diagram 2500 of illustrative steps for qualifying apeak of a cross-correlation waveform, in accordance with someembodiments of the present disclosure.

Step 2502 may include processing equipment calculating the absolutevalue of a cross-correlation output. The cross-correlation output may begenerated by, for example, performing suitable steps of flow diagram1800 of FIG. 18. Calculation of the absolute value may aid indetermining characteristics of the cross-correlation output. In someembodiments, the cross-correlation output may be squared to ensure allpositive values for further analysis. Any suitable mathematicaltechnique may be used to condition the cross-correlation output.

Step 2504 may include the processing equipment identifying a peak in thecross-correlation output of step 2502 using any suitable technique. Step2504 may include locating a maximum value in the cross-correlationoutput, locating a zero in the first derivative of the cross-correlationoutput, calculating a second derivative value (e.g., to determinewhether any extrema are minima or maxima), any other suitable peaklocating calculation, or any combination thereof. In some embodiments,step 2504 may include applying curve fitting to the cross-correlationoutput. For example, the processing equipment may fit a function, suchas a Gaussian profile or a polynomial, to a candidate peak bycalculating one or more parameters of the function. In some embodiments,identifying a peak may include identifying an interval in thecross-correlation domain corresponding to the peak, identifying acenterline of a peak, identifying any other suitable characteristicvalues, or any combination thereof.

Step 2506 may include the processing equipment generating a thresholdbased on the cross-correlation output of step 2502. In some embodiments,the threshold value may be calculated based on statistical analysis ofthe cross-correlation output. For example, the processing equipment maycalculated a mean, standard deviation, or both, of the cross-correlationoutput and generate a threshold value based on this calculation. In anillustrative example, the processing equipment may generate a thresholdequal to eight times the standard deviation of the cross-correlationoutput. In some embodiments, threshold values may be stored in adatabase (e.g., a look-up table), and may be recalled based on one ormore signal metrics (e.g., statistical values), any other suitableinformation (e.g., subject identification), or any combination thereof.The threshold value of step 2506 may be a height threshold,height-to-width threshold, peak area (e.g., integral ofcross-correlation output over peak domain) threshold, any other suitablethreshold value of a peak characteristic, or any combination thereof.

Step 2508 may include the processing equipment determining whether theidentified peak of step 2504 exceeds the threshold of step 2506. Step2508 may include a comparison of the peak value (i.e., maximum value ofthe cross-correlation output in the peak domain) to the threshold value.For example, step 2508 may include computing a difference, ratio, anyother suitable comparative quantity, or any combination thereof. If thepeak value is determined to exceed the threshold value, the identifiedpeak may be qualified as a physiological peak, as shown by step 2512. Ifthe peak value is determined not to exceed the threshold value, theidentified peak may be disqualified as a physiological peak, as shown bystep 2510. In some embodiments, step 2508 may include comparing multiplecharacteristic of the identified peak to corresponding threshold values.For example, if the peak value is determined to exceed a threshold valueand the height-to-width ratio value of the peak exceeds anotherthreshold, the identified peak may be qualified as a physiological peak,as shown by step 2512.

Step 2510 may include the processing equipment disqualifying theidentified peak of step 2504 based on the comparison of step 2508. Insome embodiments, disqualification may include removing the identifiedpeak from further consideration, calculation, or processing.

Step 2512 may include the processing equipment qualifying the identifiedpeak of step 2504 based on the comparison of step 2508. In someembodiments, qualification may include subjecting the identified peak tofurther consideration, calculation, or processing.

FIG. 26 is a plot 2600 of an illustrative cross-correlation output 2602and a threshold 2630, in accordance with some embodiments of the presentdisclosure. The abscissa of plot 2600 is presented in units ofcross-correlation lag, while the ordinate is scaled in arbitrary units,with zero notated. Note that cross-correlation output 2602 is the resultof an absolute value calculation, and includes all positive values witha baseline of zero. Cross-correlation output 2602 includes at least foursegments (i.e., segments 2606, 2608, 2610, and 2612, along with segmentsnot shown). Peak 2604 is located within segment 2610, and includes anumber of minor peaks within its envelope. The standard deviation ofcross-correlation output 2602 is shown by line 2620, a difference 2622from the baseline. In an illustrative example, threshold 2630 may beused to qualify a peak of cross-correlation 2602. In the illustratedembodiment, the difference 2632 of threshold 2630 from the baseline iseight times difference 2622. As illustrated, peak 2604 exceeds threshold2630, and accordingly, the processing equipment may qualify peak 2604based on this comparison. Under some circumstances, such as, forexample, a higher threshold (not shown), the processing equipment maydisqualify peak 2604.

FIG. 27 is a flow diagram 2700 of illustrative steps for qualifying apeak of a cross-correlation waveform based on a peak comparison, inaccordance with some embodiments of the present disclosure.

Step 2702 may include processing equipment calculating the absolutevalue of a cross-correlation output. The cross-correlation output may begenerated by, for example, performing suitable steps of flow diagram1800 of FIG. 18. Calculation of the absolute value may aid indetermining characteristics of the cross-correlation output. In someembodiments, the cross-correlation output may be squared, and optionallyre-scaled, to ensure all positive values for further analysis. Anysuitable mathematical technique may be used to condition thecross-correlation output.

Step 2704 may include the processing equipment identifying the highestpeak in the cross-correlation output of step 2702 using any suitabletechnique. Step 2704 may include locating a maximum value in thecross-correlation output, locating a zero in the first derivative of thecross-correlation output, calculating a second derivative value (e.g.,to determine whether extrema are minima or maxima), any other suitablepeak locating calculation, or any combination thereof. In someembodiments, step 2704 may include applying curve fitting to thecross-correlation output. For example, the processing equipment may fita function, such as a Gaussian profile or a polynomial, to a candidatepeak by calculating one or more parameters of the function. In someembodiments, identifying a peak may include identifying an interval inthe cross-correlation domain corresponding to the peak, identifying acenterline of a peak, identifying any other suitable characteristicvalues, or any combination thereof. In some embodiments, step 2704 mayinclude comparing multiple peaks to identify the highest peak.

Step 2706 may include the processing equipment identifying the secondhighest peak in the cross-correlation output of step 2702 using anysuitable technique. Step 2706 may include locating a maximum value inthe cross-correlation output, locating a zero in the first derivative ofthe cross-correlation output, calculating a second derivative value(e.g., to determine whether extrema are minima or maxima), performingany other suitable peak locating calculation, or any combinationthereof. In some embodiments, step 2706 may include applying curvefitting to the cross-correlation output. For example, the processingequipment may fit a function, such as a Gaussian profile or apolynomial, to a candidate peak by calculating one or more parameters ofthe function. In some embodiments, identifying a peak may includeidentifying an interval in the cross-correlation domain corresponding tothe peak, identifying a centerline of a peak, identifying any othersuitable characteristic values, or any combination thereof. In someembodiments, step 2704 may include comparing multiple peaks to identifythe second highest peak. In some embodiments, the processing equipmentmay exclude one or more portions of the cross-correlation output frombeing considered as including the second peak. For example, theprocessing equipment may require that the second peak not be part of thesame segment as that of the highest peak of step 2704. In a furtherexample, the processing equipment may require that the second peak notbe part of the same segment as that of the highest peak of step 2704,nor neighboring segments.

In some embodiments, peak height may be calculated based on an absolutemaximum value, calculated relative to a baseline, calculated relative toa negative peak minimum (e.g., positive peak to negative peakamplitude), calculated using any other suitable technique, or anycombination thereof. For example, depending upon the local baseline ofthe cross-correlation output, the highest peak need not have an absolutevalue higher than the second highest peak (e.g., if the baseline of thesecond highest peak is sufficiently larger than the baseline of thehighest peak). Any suitable criteria may be used to identify the highestand second highest peaks of steps 2704 and 2706, respectively.

Step 2708 may include the processing equipment computing a ratio of thesecond high highest peak height of step 2706 to the highest peak heightof step 2704. Step 2710 may include determining whether the computedratio of step 2708 is larger than a threshold value. If the ratio isdetermined to be greater than the threshold value at step 2710,indicating the second highest peak is not sufficiently small relative tothe highest peak, the identified highest peak may be disqualified, asshown by step 2714. If the ratio is determined to be less than or equalto the threshold value at step 2710, indicating the second highest peakis sufficiently small relative to the highest peak, the identifiedhighest peak may be qualified, as shown by step 2712. The thresholdvalue may be any suitable value between zero and one. For example, thethreshold value may be in the range of 0.6-0.8, in accordance with someembodiments of the present disclosure. In some embodiments, thethreshold value may be generated based at least in part from thecross-correlation output. For example, although not shown in flowdiagram 2700, step 2506 of flow diagram 2500 may be performed as partof, or prior to, performing step 2710.

FIG. 28 is a plot 2800 of an illustrative cross-correlation output 2802under noisy conditions, in accordance with some embodiments of thepresent disclosure. The abscissa of plot 2800 is presented in units ofcross-correlation lag, while the ordinate is scaled in arbitrary units.Segment boundaries 2810 are displayed in plot 2800 as dashed lines forreference. Cross-correlation output 2802 exhibits peak 2804 andrelatively smaller peak 2806. Peak 2804 is due to noise, and not due toa physiological pulse. Peak 2806, observed to be significantly smallthan peak 2804, is due to a physiological pulse. In some circumstances,cross-correlation outputs that exhibit large noise components, such ascross-correlation output 2802, may lead to erroneous determination ofphysiological peaks. Accordingly, additional processing or analysis ofthe cross-correlation output may be performed to correctly identify thephysiological peak.

FIG. 29 is a flow diagram 2900 of illustrative steps for qualifying apeak of a cross-correlation waveform based on a segment sum, inaccordance with some embodiments of the present disclosure. The steps offlow diagram 2900 may be especially useful in circumstances in which across-correlation output exhibits relatively large noise components.

Step 2902 may include the processing equipment calculating the absolutevalue of a cross-correlation output. The cross-correlation output may begenerated by, for example, performing suitable steps of flow diagram1800 of FIG. 18. Calculation of the absolute value may aid indetermining characteristics of the cross-correlation output. In someembodiments, the cross-correlation output may be squared, and optionallyre-scaled, to ensure all positive values for further analysis. Anysuitable mathematical technique may be used to condition thecross-correlation output.

Step 2904 may include the processing equipment summing the amplitudeswithin each segment of the cross-correlation output. Within each segmentmay be various values of the cross-correlation output, computed atdifferent time lags. While the input to step 2902 is thecross-correlation output of N values, the output of step 2902 is a setof m values (termed the “sum output”), in which m represents the numberof segments (i.e., m is less than N). The summation of step 2904 allowsthe effects of large fluctuations in the cross-correlation output (e.g.,due to noise) to be taken into account in identifying peaks.Accordingly, singular peaks (e.g., excursions) in the cross-correlationoutput having large heights but a relatively low number of high-heightneighboring values (i.e., low density) will be diminished by performingthe summing of step 2904. Accordingly, singular peaks in thecross-correlation output having large heights and a relatively highnumber of high-height neighboring values (i.e., high density) will beenhanced by performing the summing of step 2904.

Step 2906 may include the processing equipment analyzing the sum outputof step 2904 to identify the maximum sum value. Any suitable peaklocation technique may be used in accordance with the presentdisclosure. Step 2906 may include locating a maximum value in the sumoutput, locating a zero in the first derivative of the sum output,calculating a second derivative value of the sum output (e.g., todetermine whether extrema are minima or maxima), performing any othersuitable peak locating calculation, or any combination thereof.

FIG. 30 is a plot 3000 of an illustrative pre-processed PPG signal 3002,exhibiting low frequency noise, in accordance with some embodiments ofthe present disclosure. The abscissa of plot 3000 is presented in unitsproportional to sample number, while the ordinate is scaled in arbitraryunits. PPG signal 3002 exhibits a relatively large noise component, asshown by the low frequency baseline oscillation (i.e., with half-periodshown approximately by interval 3010). The physiological pulse of PPGsignal 3002 is observed by the relatively higher frequency oscillations(i.e., with full period shown approximately by interval 3020)superimposed on the noise component.

FIG. 31 is a plot 3100 of an illustrative cross-correlation output 3102based in part on the PPG signal 3002 of FIG. 30, in accordance with someembodiments of the present disclosure. The abscissa of plot 3100 ispresented in units of cross-correlation lag, while the ordinate isscaled in arbitrary units, with a zero baseline. The three largest peaksof cross-correlation output 3102 (i.e., peak 3104, peak 3106, and peak3108) all exhibit particular characteristics relative to one another.For example, peak 3104 is slightly taller than peak 3108, both of whichare significantly taller than peak 3106. Peak 3108 has a higher densitythan peak 3104, which exhibits larger fluctuations of cross-correlationoutput within segments. Note that peak 3108 corresponds to aphysiological rate, while peak 3104 corresponds to low frequency noise.The difference in density between peak 3104 and peak 3108 may be used todetermine which peak likely corresponds to a physiological peak, asdescribed illustratively by flow diagram 2900 of FIG. 29.

FIG. 32 is a plot 3200 of the sums 3202 within each segment of theillustrative cross-correlation output 3102 of FIG. 31, in accordancewith some embodiments of the present disclosure. The abscissa of plot3200 is presented in units of segment number, while the ordinate isscaled in arbitrary units, with a zero baseline. Peak 3208, whichcorresponds to peak 3108 of FIG. 31, is the largest peak of plot 3200,with a larger peak height than peak 3204, which corresponds to peak 3104of FIG. 31. Peak 3206, which corresponds to peak 3106 of FIG. 31, doesnot have the highest peak height with or without summing within eachsegment, and accordingly need not be considered a physiological rateunder some circumstances. The use of summing, as described by flowdiagram 2900 of FIG. 29, allows the peak associated with a physiologicalpulse to be identified for relatively noisy PPG signals. The identifiedpeak may be automatically qualified or it may be further analyzed andqualified or disqualified using one or more techniques described inconnection with flow diagrams 2300, 2500, and 2700.

FIG. 33 is a flow diagram 3300 of illustrative steps for identifying asegment of a cross-correlation output based on a segment analysis, inaccordance with some embodiments of the present disclosure.

Step 3302 may include processing equipment calculating the absolutevalue of a cross-correlation output. The cross-correlation output may begenerated by, for example, performing suitable steps of flow diagram1800 of FIG. 18. Calculation of the absolute value may aid indetermining characteristics of the cross-correlation output. In someembodiments, the cross-correlation output may be squared, and optionallyre-scaled, to ensure all positive values for further analysis. Anysuitable mathematical technique may be used to condition thecross-correlation output.

Step 3304 may include the processing equipment analyzing one or moresegments of the cross-correlation output. Analyzing a segment of thecross-correlation output may include determining a maximum value,determining a shape of the cross-correlation output within the segment,performing any other suitable analysis, or any combination thereof. Insome embodiments, step 3304 may include generating an upper envelope, ofany suitable resolution, for the cross-correlation output within thesegment. In some embodiments, step 3304 may include curve fitting theupper envelope (e.g., performing a least squares polynomial regression),performing a piecewise linear regression), of any suitable resolution.For example, a pair of ascending and descending best-fit (e.g., underany suitable constraints) lines through the peaks within the segment maybe computed (e.g., see highlight 3404 of FIG. 34). In some embodiments,step 3304 may include calculating a slope of an envelope, or portionthereof, to determine a shape of the cross-correlation output within thesegment. In some embodiments, step 3304 may include determining severalcharacteristics of the cross-correlation output within the segment. Forexample, step 3304 may include determining a peak height, anddetermining a shape (e.g., up-slope, down-slope, shape of peak heightswithin the segment) of the peaks within the segment.

Step 3306 may include the processing equipment identifying a segment ofthe cross-correlation output based on the analysis of step 3304. In someembodiments, the segment may be identified based on a comparison of oneor more characteristics of the cross-correlation output within thesegment to corresponding threshold values. For example, the slope of abest-fit line (under any suitable constraints) through ascending minorpeaks within the segment may be compared with a threshold, or rangethereof, and identified based on the comparison. In some embodiments,identifying a segment of the cross-correlation output may includeidentifying a frequency corresponding to the segment. For example, thefrequency associated with a segment of the cross-correlation output(e.g., frequency associated with the corresponding segment of thecross-correlation waveform used) may be identified.

FIG. 34 is a plot 3400 showing one segment of an illustrativecross-correlation output 3402 with a segment shape highlighted byhighlight 3404, in accordance with some embodiments of the presentdisclosure. The abscissa of plot 3400 is presented in units ofcross-correlation lag, while the ordinate is scaled in arbitrary units,with a zero baseline 3406. Baseline 3406 represents the axis about whichan absolute value was calculated (i.e., an ordinate value of zero). Thecross-correlation output within a segment may include multiple minorpeaks that collectively form a peak, as shown by cross-correlationoutput 3402. The minor peaks of cross-correlation output 3402 at eitherboundary of the segment may be relatively small, and may increasetowards the center of the segment. Highlight 3404 is a linear fit to theminor peak heights within the segment. Note that highlight 3404 need notbe linear, and may be any suitable shape, or piecewise combinationthereof. Any suitable shape characteristic of a cross-correlation outputwithin a segment may be used to identify a segment as corresponding to aphysiological pulse. For example, the symmetry of a peak ofcross-correlation output 3402 may be determined by comparing theabsolute values of the two slopes (i.e., positive up-slope and negativedown-slope) of highlight 3404. In a further example, the deviationbetween the minor peaks of cross-correlation output 3402 and a highlight(e.g., highlight 3404 or other suitable highlight of any suitable shape)may be calculated and compared to a threshold.

FIG. 35 is a flow diagram 3500 of illustrative steps for providing acombined autocorrelation of a physiological signal using one or moreprior autocorrelations, in accordance with some embodiments of thepresent disclosure.

Step 3502 may include processing equipment performing an autocorrelationon conditioned physiological data (e.g., a window of data). In someembodiments, the autocorrelation of step 3502 may include correlating afirst portion of the window of data with a second portion of the windowof data. The first and second portions may be exclusive of one another,may share one or more samples, or may be selected by any other suitablepartition of the window of data.

The window of data of step 3502 may be derived from the output of aphysiological sensor, pre-processed (e.g., using pre-processor 320), andthen stored in any suitable memory or buffer (e.g., queue serial module72 of FIG. 2), for further processing by the processing equipment. Insome embodiments, the window of data may be recalled from data stored inmemory (e.g., RAM 54 of FIG. 2 or other suitable memory) for subsequentconditioning and processing. In some embodiments, the window size (e.g.,the number of samples or time interval of data to be buffered) of datais selected to capture multiple periods of oscillatory physiologicalactivity. For example, a six second window may be used to capture aboutsix pulse wave of a photoplethysmograph of a nominal resting adult witha pulse rate of approximately 60 BPM (i.e., 1 Hz). It will be understoodthat any suitable window size may be used in accordance with the presentdisclosure, and six seconds is used for illustrative purposes. Signalconditioning may include removing DC components, low frequencycomponents, or both, from the window of data. In some embodiments, avarying baseline may be removed from the window of data (i.e.,de-trending) to constrain the data average to zero.

Step 3504 may include the processing equipment combining theautocorrelation output of step 3502 with one or more priorautocorrelation outputs, to generate a combined autocorrelation output.In some embodiments, the autocorrelation output may be averaged (e.g.,using an ensemble average, weighted average, or any other suitableaverage) with one or more prior autocorrelation outputs. For example,step 3504 may include applying an infinite impulse response (IIR)filter, or a finite impulse response (FIR) filter, to the current andprior autocorrelation outputs. Combining autocorrelation output withprior autocorrelation output(s) may reduce the effects of sudden changesor noise while the processing equipment, for example, is in Search Mode.

Step 3506 may include the processing equipment providing the combinedautocorrelation output as an input to a cross-correlation calculation(e.g., as described by step 1808 of flow diagram 1800 of FIG. 18). Insome embodiments, the combined autocorrelation output may be queued inany suitable memory storage for use in calculating a cross-correlationoutput. In some embodiments, the combined autocorrelation may begenerated by an autocorrelation module, and may be provided to across-correlation module. While the combined autocorrelation output isdescribed as being inputted into a cross-correlation module, it will beunderstood that the combined autocorrelation output can be used in allmodules and steps disclosed herein that use an autocorrelation.

FIG. 36 is a flow diagram 3600 of illustrative steps for providing acombined autocorrelation using various window sizes and templates, inaccordance with some embodiments of the present disclosure.

Step 3602 may include processor 312 performing multiple autocorrelationson conditioned physiological data. Step 3602 may include using differentsized templates, different sized windows of data, or both, to generatemultiple autocorrelation outputs. In some embodiments, different windowsof data may be selected from the physiological data. An autocorrelationmay be performed for each of the different windows, using any suitableautocorrelation templates. In some embodiments, a particular window ofdata may be partitioned into multiple sets of first and second portions,and an autocorrelation may be performed for each set. For example, a sixsecond window of data may be buffered. The most recent one second ofdata of the window may be used as a first template, and the most recenttwo seconds of data of the window may be used as a second template. Afirst autocorrelation may be performed using the first template and theentire six second window, and a second autocorrelation may be performedusing the second template and the entire six second window.

Step 3604 may include the processing equipment combining the multipleautocorrelation outputs of step 3602. In some embodiments, combining mayinclude averaging (e.g., ensemble averaging, weighted averaging, anyother suitable averaging) the multiple autocorrelation outputs togenerate a single, combined autocorrelation output. Combining multipleautocorrelation outputs may reduce the effects of sudden changes ornoise while the processing equipment is in, for example, Search Mode.Because autocorrelations will typically contain peaks at a lag of zeroand a lags that correspond to the periodic component of a signal, it ispossible to combine multiple autocorrelations of differently sizedtemplates and of different window sizes to minimize noise such asnon-periodic noise.

Step 3606 may include the processing equipment providing the combinedautocorrelation output as an input to a cross-correlation calculation(e.g., as described by step 1808 of flow diagram 1800 of FIG. 18). Insome embodiments, the combined autocorrelation output may be queued inany suitable memory storage for use in calculating a cross-correlationoutput. In some embodiments, the combined autocorrelation may begenerated by an autocorrelation module, and may be provided as input toa cross-correlation module. While the combined autocorrelation output isdescribed as being inputted into a cross-correlation module, it will beunderstood that the combined autocorrelation output may be used in allmodules and steps disclosed herein that use an autocorrelation.

FIG. 37 is a flow diagram 3700 of illustrative steps for performing across-correlation using a library 3750 of cross-correlation waveforms3752, in accordance with some embodiments of the present disclosure. Theillustrative steps of flow diagram 3700 may be used to generate across-correlation waveform, which may be used in Search Mode todetermine initialization parameters.

Step 3702 may include processing equipment performing across-correlation of an autocorrelation output with one or morecross-correlation waveforms. In some embodiments, the one or morecross-correlation waveforms may be recalled, or otherwise accessed fromlibrary 3750. The autocorrelation output may be generated using anysuitable technique such as the techniques disclosed herein (e.g., theillustrative steps of flow diagram 500 of FIG. 5, flow diagram 900 ofFIG. 9, or other suitable technique). In some embodiments, thecross-correlation of step 3702 may include one or more segments, eachhaving particular characteristics, as described by flow diagram 1900 ofFIG. 19. In some embodiments, the cross-correlation waveform may includemultiple segments, each including multiple pulses. In some embodiments,the cross-correlation of step 3702 may be performed sequentially overtime with different cross-correlation waveforms. For example, theprocessing equipment may perform one cross-correlation every second andsequence through multiple cross-correlation waveforms over time. In someembodiments, the cross-correlation of step 3702 may be performed inparallel with the same autocorrelation output and differentcross-correlation waveforms.

Library 3750 of cross-correlation information may include stored basewaveforms (e.g., for generating cross-correlation waveforms), sample PPGsignals (e.g., for use as base waveforms in generating cross-correlationwaveforms), algorithms (e.g., computer-readable instructions forperforming a cross-correlation), cross correlation waveforms, any othersuitable information, or any combination thereof. Library 3750 may bestored in any suitable type of memory (e.g., ROM 52 of physiologicalmonitoring system 10 of FIGS. 1-2), or combinations thereof, and may beformatted using any suitable database format.

Cross-correlation waveforms 3752 may be stored in suitable memory aspart of library 3750. In some embodiments, cross-correlation waveforms3752 may include one or more cross-correlation waveforms, each having aparticular number of segments and spanning a particular range inphysiological pulse frequency (e.g., a particular BPM range). In theillustrated example, cross-correlation waveforms 3752 include at leastfour waveforms, shown by “WAVEFORM 1”-“WAVEFORM 4.” The waveforms eachinclude a particular number of segments, ranging from, for example, 9 to28 segments. Additionally, the waveforms each span a particular BPMrange, from, for example, 25 to 300 BPM. WAVEFORM 1 spans the BPM rangeof 25 to 295 BPM, by 28 segments (e.g., in increments of 10 BPM), whileWAVEFORM 4 spans the BPM range of 25-105 BPM, by 9 segments (e.g., inincrements of 10 BPM). Accordingly, different cross-correlationwaveforms may be preferred for use in different circumstances. By usingdifferent cross-correlation waveforms, either in parallel orsequentially, it is possible to more accurately identify a segmentcorresponding to a subject's physiological pulse rate. For example,WAVEFORM 4 may be preferred for use with physiological data from aresting adult, rather than a neonate or active adult because it containssegments in the range of 25-105 BPM. As a further example, WAVEFORM 2may be preferred when a subject's heart rate is 60 BPM because itcontains a segment corresponding to 60 BPM.

Step 3704 may include the processing equipment providing thecross-correlation output from step 3702 for further analysis. In someembodiments, the cross-correlation output may be generated by across-correlation module, and may be provided as an input to an analysismodule (e.g., as shown by step 1810 of flow diagram 1800 of FIG. 18). Insome embodiments, the analysis module may process the cross-correlationoutput according to one or more of flow diagrams 1800, 2300, 2500, 2700,2900, and 3300 to identify a desired segment.

The foregoing discussion of FIGS. 18-37 relate to Search Modeembodiments that use a cross-correlation waveform and refer toidentifying peaks, identifying segments, and determining one or morealgorithm settings. It will be understood that the identification ofsegments is optional and the identified peak information may be directlyused to determine one or more algorithm settings. For example, the peakinformation may be used to determine physiological rates, periods, orlikely ranges thereof. As shown in FIG. 37, identification of a peak inWAVEFORM 1 may indicate that the pulse rate is within a specific 10 BPMrange because the BPMs of segments are spaced 10 BPM apart. Thisinformation, or the peak information, may be used to set one or morealgorithm settings. The algorithm settings may include settings of afilter such as, for example, a high and low frequency cutoff value of aband pass filter (e.g., a frequency range), a representative frequencyvalue, a set of one or more coefficients, one or more settings of athreshold calculation, any other suitable parameters, or any combinationthereof.

In some embodiments, Search Mode may include the processing equipmentqualifying one or more initialization parameters (e.g., as shown by step410 of flow diagram 400 of FIG. 4). Qualification of the determinedinitialization parameters may provide a more robust operation, andreduce the misidentification of noise activity as a physiological rate.For example, Qualification Techniques may be used to detect instances inwhich the system has locked on to one half, double, or other multiple ofthe actual physiological rate. Whereas determining initializationparameters may provide an estimate of a physiological rate, or rangethereof, qualification may provide an indication of how consistent theestimate is, and how well the estimate characterizes a physiologicalpulse. In some embodiments, the Qualification Techniques discussed inthe context of Search Mode may also be used to qualify a calculated ratein Locked Mode.

FIG. 38 is a flow diagram 3800 of illustrative steps for qualifying ordisqualifying initialization parameters and/or calculated rates using across-correlation, in accordance with some embodiments of the presentdisclosure.

Step 3802 may include processing equipment receiving qualificationinformation. Qualification information may include initializationparameters, a calculated rate, qualification metrics, any other suitableinformation used in qualifying initialization parameters and/orcalculated rates, or any combination thereof. In some embodiments thequalification information may be generated at an earlier time, andstored in suitable memory (e.g., RAM 54, ROM 52, or other memory ofphysiological monitoring system 10 of FIGS. 1-2). Accordingly, in someembodiments, step 3802 may include recalling the qualificationinformation from memory. In some embodiments, a single processor,module, or system may determine, store or otherwise process thequalification information and perform steps 3804-3808, and accordingly,step 3802 need not be performed.

Step 3804 may include the processing equipment scaling one or morepredefined templates based on the qualification information. Thepredefined templates may include asymmetrical pulses without a dicroticnotch, asymmetrical pulses with a dicrotic notch, approximatelysymmetrical pulses without a dicrotic notch, pulses of any otherclassification, any other suitable type of template, or any combinationthereof. In some embodiments, the predefined templates may be derivedfrom a subject's PPG signals. In some embodiments, the predefinedtemplates may be mathematical functions, mathematical approximations toa PPG signal, any other suitable mathematical formulation, or anycombination thereof. In some embodiments, scaling a predefined templatemay include stretching or compressing the template in the time domain(or corresponding sample number domain) to match a characteristic timescale of the template to that associated with the qualificationinformation. For example, if an initialization parameter estimates thephysiological rate to be 1 Hz, a predefined template may be scaled tocorrespond to 1 Hz. The period associated with the initializationparameters, or the calculated rate, will be referred to herein as “P”,and may be used for qualification. Scaled templates may be referred toherein as “reference waveforms.”

Step 3806 may include the processing equipment performing across-correlation of the scaled template(s) of step 3804 and thephysiological signal. The physiological signal may be conditioned beforebeing used in the cross-correlation. The signal conditioning may includeremoving DC components, low frequency components, or both, from thesignal. In some embodiments, a varying baseline may be removed from thesignal (i.e., de-trending) to constrain the data average to zero. Thesignal may also be normalized so that the amplitude of the signal isone. The cross-correlation may be performed using any suitablealgorithm. The output of step 3806 may be a cross-correlation output,which may include a series of cross-correlation values taken for acorresponding series of time lags (or sample number lags) between thepredefined template and the physiological signal.

Step 3808 may include the processing equipment analyzing thecross-correlation output(s) of step 3806 to qualify or disqualify theinitialization parameters, the calculated rate, or both. A conditionedcross-correlation output of step 3806 may include one or more peaks,indicative of high correlation between the physiological signal and apredefined template. In some embodiments, step 3808 may includeanalyzing one or more peaks. In some embodiments, step 3808 may includeanalyzing one or more segments of the cross-correlation output. Forexample, tests described herein below such as the Symmetry Test, RadiusTest, Angle Test, Area Test, Area Similarity Test, Statistical PropertyTest, or any other suitable test, or combination thereof, may beperformed at step 3808 to analyze the one or more cross-correlationoutputs of step 3806. The processing equipment may perform any suitableanalysis at step 3808 to qualify or disqualify initializationparameters, a calculated rate, or both, associated with the one or morecross-correlation outputs. In some embodiments, when a value isdisqualified in Locked Mode, the value may still be used although a ratefilter may be modified. For example, a filter weight associated with thedisqualified value may be reduced as a result of disqualification.

FIG. 39 is a plot 3900 of an illustrative PPG signal 3902 showing onepulse of a subject, in accordance with some embodiments of the presentdisclosure. The abscissa of plot 3900 is presented in arbitrary units,while the ordinate is also presented in arbitrary units. PPG signal 3902exhibits non-zero baseline 3904, which may be, but need not be, astraight line. While PPG signal 3902 is relatively free of noise, slopedbaseline 3904 indicates a relatively low frequency noise component. Insome embodiments, PPG signal 3902 may be a raw PPG signal, a smoothedPPG signal, an ensemble averaged PPG signal, a filtered PPG signal, anyother raw or processed PPG signal, or any combination thereof. In someembodiments, PPG signal 3902 may be approximated by a mathematicalrepresentation for further processing (e.g., step 3806, step 3808, orboth, of flow diagram 3800).

FIG. 40 is a plot 4000 of a template 4002 derived from illustrative PPGsignal 3902 of FIG. 39 with baseline 3904 removed (i.e., de-trended), inaccordance with some embodiments of the present disclosure. The abscissaof plot 4000 is presented in arbitrary units, while the ordinate is alsopresented in arbitrary units. The conditioned signal derived from PPGsignal 3902 is referred to as template 4002. De-trending, or othersuitable conditioning, may be performed as part of step 3804 of flowdiagram 3800. Although the ordinate of FIG. 40 is not numerated,template 4002 may be normalized or otherwise scaled along the ordinateof plot 4000 to range from [−1,0], [−1,1], [0,1], or any other suitablerange. For example, the mean of template 4002 may be set to zero.

FIG. 41 is a plot 4100 of illustrative template 4002 of FIG. 40 scaledto different sizes for use as templates in performingcross-correlations, in accordance with some embodiments of the presentdisclosure. The abscissa of plot 4100 is presented in arbitrary units,while the ordinate is also presented in arbitrary units. Illustrativescaled templates 4104, 4106, and 4108 are generated by scaling template4002 by respective scale factors. In the illustrated example, with theabscissa beginning at zero, the pulse period is scaled by one-half,one-fourth, and one-eighth, to generate scaled templates 4104, 4106, and4108, respectively.

The plots of FIGS. 39-41 illustrate one technique for creating templatesfor use in qualifying initialization parameters and/or calculated rates.The starting pulse in FIG. 39 may be selected from the subject beingmonitored or may be selected offline from a library of stored PPGsignals from subjects. In some embodiments, the starting pulse may begenerated mathematically (e.g., based on one or more functions) ormanually. In some embodiments, the processing equipment may generate theone or more templates for each qualification calculation. In someembodiments, a library of templates for one or more pulse shapes may bepre-generated and/or pre-stored in memory and the processing equipmentmay select the appropriate template or templates for use in thequalification based on the received qualification information. Forexample, 281 templates may be stored for each pulse shape, one for eachBPM in the range of 20-300 BPM. This is merely illustrative and anysuitable number of templates may be stored of any suitable BPMresolution and covering any suitable range of BPMs. The processingequipment may select an appropriate template based on rate informationin the qualification information. In some embodiments, the pulse shapeof the templates may vary as a function of BPM. For example, at low BPMvalues (e.g., less than about 60 BPM) the pulse shape may beasymmetrical with a dicrotic notch. However, as the BPM value increases,the pulse shape may become more symmetrical and the dicrotic notch maybecome relatively smaller and eventually not included in the pulseshape.

FIG. 42 is a plot 4200 of output 4202 of an illustrativecross-correlation between a PPG signal or a signal derived thereof and apredefined template, in accordance with some embodiments of the presentdisclosure. The abscissa of plot 4200 is presented in units ofcross-correlation lag, while the ordinate is presented in arbitraryunits, with zero notated. The shape of cross-correlation output 4202indicates a relatively close match between the template and the PPGsignal. In some embodiments, more than one cross-correlation output maybe generated by using more than one scaled template. Accordingly, insome embodiments, cross-correlation outputs corresponding to multipletemplates may be evaluated (e.g., using any of the cross-correlationanalyses of the present disclosure) to determine which template mostclosely matches the PPG signal.

FIG. 43 is a flow diagram 4300 of illustrative steps for qualifying ordisqualifying initialization parameters and/or calculated rates based onan analysis of two segments of a cross-correlation, in accordance withsome embodiments of the present disclosure. The illustrative steps offlow diagram 4300 may be referred to as the “Symmetry Test.”

Step 4302 may include processing equipment receiving a cross-correlationsignal (e.g., generated according to step 3806 of FIG. 38) as an input.In some embodiments, a cross-correlation signal may be across-correlation output (e.g., output of step 3806 of flow diagram 3800of FIG. 38). In some embodiments, the cross-correlation signal may begenerated by a cross-correlation module. In some embodiments thecross-correlation signal may be generated at an earlier time, and storedin suitable memory. Accordingly, in some embodiments, step 4302 mayinclude recalling the stored cross-correlation signal from the memory.In some embodiments, a single processor, module, or system may performthe cross-correlation and steps 4304-4308, and accordingly, step 4302need not be performed.

Step 4304 may include the processing equipment selecting any twosuitable segments, having any suitable length (e.g., one full period, ormore, or less), of the cross-correlation signal of step 4302. Periodhere refers to a period associated with an initialization parameter or acalculated rate. The cross-correlation signal may include a series ofdata points exhibiting peaks and valleys. The two segments may beselected on either side of a peak or valley, in symmetric locations(e.g., see FIGS. 44-45 for a more detailed discussion of the segments'symmetry). For example, the segments may share a single point at thezenith of a peak or the nadir of a valley, and the segments may extendin opposite directions. In a further example, the segments need notshare any points, and a gap may exist between the segments.

FIG. 44 is a plot 4400 of an illustrative cross-correlation signal 4402,showing several reference points for selecting two segments andgenerating a symmetry curve, in accordance with some embodiments of step4304 of the present disclosure. The reference points may be used togenerate a series of points (u_(j), v_(j)) in a Cartesian plane (orother suitable coordinate system), termed a “symmetry curve,” as shownby Eqs. 18 and 19.

u _(j) =f(x ₀ +Δx _(j))  (18)

v _(j) =f(x ₀₀ −Δx _(j))  (19)

Reference points x₀ and x₀₀ may be the same point located at a peak orvalley (i.e., x₀=x₀₀ as shown by point 4404 or point 4414), or points x₀and x₀₀ may be different points, for example, symmetrical about a peak(or valley) of cross-correlation signal values f(x) (e.g., as shown bypoints 4406 and 4408, or points 4410 and 4412). Note that x may includediscrete values associated with a sampled signal. Shift Δx_(j) may rangefrom zero to any suitable number, generating two segments (i.e., thefirst and second segments, or vice versa) with data points at(x₀+Δx_(j)) and (x₀₀−Δx_(j)) for a suitable span of index j values. Ifthe cross-correlation signal is symmetric (about the midpoint of x₀ andx₀₀), as shift Δx_(j) increases, u_(j) and v_(j) will be equalnumerically. The series of points (u_(j), v_(j)) will accordinglygenerate a straight line of unity slope through the origin. Anydeviation between u_(j) and v_(j) may be attributed to asymmetry of thecross-correlation output, and will accordingly cause the series ofpoints (u_(j), v_(j)) to not fall in a straight line of unity slopethrough the origin.

Step 4304 may include the processing equipment selecting any twosuitable segments, of any suitable length (e.g., one full period, ormore, or less), of a cross-correlation output (e.g., cross-correlationsignal 4402). For example, the portion of cross-correlation signal 4402between points 4408 and 4410 may be a first segment, with the secondsegment extending leftward from point 4406 to point 4420. In a furtherexample, the portion of cross-correlation signal 4402 between points4408 and 4410 may be a first segment, with a second segment extendingrightward from point 4412 to point 4418. In a further example, theportion of cross-correlation signal 4402 between points 4404 and 4414may be a first segment, and a second segment may extend from point 4414to points 4416.

Step 4306 may include the processing equipment analyzing the twosegments of step 4304. In some embodiments, step 4306 may includeanalyzing the symmetry of the two segments. For example, step 4306 mayinclude the processing equipment generating a symmetry curve to analyzethe symmetry between the first and second segments. FIG. 45 is a plot4500 of an illustrative symmetry curve 4502 generated using two segmentsof a cross-correlation signal, in accordance with some embodiments ofthe present disclosure. The demarcations of the abscissa and ordinate ofplot 4500 are scaled in arbitrary, but similar, units. Symmetry curve4502 may be generated, for example, by tracing out a series of points(u_(j), v_(j)) in a Cartesian plane (or other suitable coordinatesystem), as shown by Eqs. 18 and 19. Symmetry curve 4502 is observed topass roughly through the origin at (0,0) and have a slope of roughlyone, with some relatively small deviation. Line 4504 shows the linethrough the origin with a slope of unity, for reference. In somecircumstances, symmetry curve 4502 may be determined to be shapedsufficiently well (e.g., based on the analysis of step 4306 of flowdiagram 4300), and a set of initialization parameters may be qualified.

In some embodiments, step 4306 may include comparing a symmetry curve toa reference curve (e.g., a line through the origin with a slope ofunity). For example, a variability metric such as V₁ may be computedaccording to Eq. 20a:

$\begin{matrix}{V_{1} = {\sum\limits_{i = 1}^{M}\left( {{S\left( x_{i} \right)} - {y\left( x_{i} \right)}} \right)^{2}}} & \left( {20a} \right)\end{matrix}$

in which S(x_(i)) is a symmetry curve value (e.g., a value of symmetrycurve 4502) at point i of M data points, and y(x_(i)) corresponds to areference curve (e.g., line 4504 in which y(x_(i))=x_(i)). Any suitablevariability metric may be used to evaluate the symmetry curve, orotherwise the symmetry of the two segments.

In some embodiments, step 4306 may include comparing the two segmentswithout first generating a symmetry curve or using a reference curve.For example, a variability metric such as may be computed according toEq. 20b:

$\begin{matrix}{V_{2} = {\sum\limits_{j = 1}^{M}{\left( {u_{j} - v_{j}} \right)^{2}.}}} & \left( {20b} \right)\end{matrix}$

As a further example, a correlation coefficient between the two segmentsmay be computed. Any suitable correlation coefficient computation may beused including, for example, Pearson's correlation coefficient.

In some embodiments, multiple pairs of first and second segments may beselected at step 4304 and analyzed at step 4306. For example, a firstpair of segments sharing a single common point may each extend for afull pulse period, while a second pair of segments sharing the samecommon point may extend for a half pulse period. In a further example,different pairs of segments may be selected each referenced to differentpeaks or valleys of the cross-correlation signal.

Step 4308 may include the processing equipment qualifying, ordisqualifying, initialization parameters, a calculated rate, or both,based on the analysis of step 4306. In some embodiments, one or moremetric may be inputted into a classifier (e.g., a neural network). Insome embodiments, qualification (or disqualification) may depend on acomparison between one or metrics computed at step 4306 and one or morethreshold values. For example, a variability metric (e.g., V₁ of Eq. 20aor any other suitable metric) may be compared with a threshold, and ifthe variability metric does not exceed the threshold value, theassociated initialization parameters (or calculated rate) may bequalified. Accordingly, if the variability metric exceeds the thresholdvalue, the associated (e.g., current, previously selected)initialization parameters, calculated rate, or both, may be disqualified(and vice versa). In some embodiments, a disqualification at step 4308may trigger steps 4304-4308 to repeat (i.e., two different segments maybe selected from the same cross-correlation signal for analysis). Insome embodiments, a disqualification at step 4308 may trigger steps4302-4308 to repeat (i.e., two segments are selected from a differentcross-correlation signal for analysis). In some embodiments, adisqualification at step 4308 may trigger an analysis different thanthat of flow diagram 4300 to be performed to either qualify ordisqualify the initialization parameters, calculated rate, or both,associated with the cross-correlation signal.

FIG. 46 is a flow diagram 4600 of illustrative steps for qualifying ordisqualifying initialization parameters and/or calculated rates based onan analysis of offset segments of a cross-correlation signal, inaccordance with some embodiments of the present disclosure. In someembodiments, the illustrative steps of flow diagram 4600 aid inpreventing a double-rate/half-period condition, or other condition inwhich period P is not indicative of a physiological rate.

Step 4602 may include processing equipment receiving a cross-correlationsignal (e.g., generated according to step 3806 of FIG. 38) as an input.In some embodiments, the cross-correlation signal may be generated by across-correlation module. In some embodiments the cross-correlationsignal may be generated at an earlier time, and stored in suitablememory. Accordingly, in some embodiments, step 4602 may includerecalling the stored cross-correlation signal from the memory. In someembodiments, a single processor, module, or system may perform thecross-correlation and steps 4604-4618, and accordingly, step 4602 neednot be performed.

Step 4604 may include the processing equipment selecting two segments ofthe cross-correlation signal of step 4602. The cross-correlation signalmay include a series of data points exhibiting peaks and valleys. Thetwo segments may be of equal length, offset by a quarter length of theperiod P associated with the calculated rate, initialization parameters,or both. In some embodiments, the first and second segments may eachhave a length equal to period P, although they may be any suitablelength as long as the segments are of approximately equal length. Thetwo segments may be selected from any suitable portion of thecross-correlation signal. Note that the two segments will be referred toas Segment1 and Segment2, or the first segment and the second segment,although the designations are arbitrarily chosen for illustrationpurposes (e.g., the first and second segments may be interchanged inaccordance with the present disclosure).

Following step 4604, the processing equipment may perform step 4606,4612, or both (e.g., simultaneously or sequentially) in accordance withsome embodiments of the present disclosure. In some embodiments, the“Radius Test” (i.e., steps 4606-4610) may be performed, and the “AngleTest” (i.e., steps 4612-4616) need not be performed. In someembodiments, the “Angle Test” may be performed, and the “Radius Test”need not be performed. In some embodiments, one of the “Radius Test” andthe “Angle Test” may be performed initially, and depending upon theoutcome of the test (e.g., qualify, disqualify) the other test may beperformed.

Step 4606 may include the processing equipment calculating the radiusbased on the two segments of step 4604, using Eq. 21. In Eq. 21,Segment1_(j) and Segment2_(j) are the cross-correlation output f(x)values of the first and second segments, respectively, evaluated forindex j, which ranges from zero to N−1 for segments with N data points.Note that x may include discrete values associated with a sampledsignal. With reference to Eqs. 22 and 23, Segment1 originates at pointx₀ and extends rightward with index j in the Cartesian plane, and theorigin of Segment2 is offset by a quarter period P relative to the firstsegment. Also note that Δx_(j) may increase linearly with j. Forexample, Δx_(j) may be given by Eq. 24, in which Δx is the data pointspacing in the domain.

$\begin{matrix}{{Radius}_{j} = \sqrt{{{Segment}1}_{j}^{2} + {{Segment}2}_{j}^{2}}} & (21) \\{{{Segment}\; 1_{j}} = {f\left( {x_{0} + {\Delta \; x_{j}}} \right)}} & (22) \\{{{Segment}2}_{j} = {f\left( {x_{0} + \frac{P}{4} + {\Delta \; x_{j\;}}} \right)}} & (23) \\{{\Delta \; x_{j}} = {j\; \Delta \; x}} & (24)\end{matrix}$

The radius of step 4606, as computed using Eq. 21, will be a constant ifthe period P identically matches the period of the cross-correlationoutput f(x), and has strictly sinusoidal character. Variations in theradius with index j may be attributed to the shape of thecross-correlation output, deviations between period P and thecharacteristic period of the cross-correlation signal, any othersuitable characteristic of the cross-correlation signal, or anycombination thereof.

Step 4608 may include the processing equipment identifying the maximumand minimum radii step 4606, and calculating a ratio as shown, forexample, by Eq. 25.

$\begin{matrix}{{Ratio} = \frac{{Radius}_{MAX}}{{Radius}_{MIN}}} & (25)\end{matrix}$

The ratio of the maximum (Radius_(MAX)) and minimum (Radius_(MIN)) radiiprovide a variability metric, indicating variability in the calculatedradii values. Note that if the radii values have low variability (i.e.,are all substantially the same value), the ratio is near one. Thepresence of variability will necessarily cause the ratio to assume avalue greater than one. In some embodiments, variability metrics otherthan the ratio of Eq. 25 may be calculated from the radii values. Anysuitable variability metric may be used in accordance with the presentdisclosure.

Step 4610 may include the processing equipment comparing the ratio ofstep 4608 to one or more threshold values. In some embodiments, a fixedthreshold may be used for comparison. In some embodiments, a variablethreshold may be used. For example, threshold value(s) may be based onthe value of the period P, subject information (e.g., subject history,medical history, medical procedure), segment length, whetherinitialization parameters or calculated rates are being qualified, anyother suitable information, or any combination thereof. In someembodiments, the threshold value(s) may be stricter in Search Modeversus Locked Mode. The stricter threshold(s) may prevent the algorithmfrom locking onto the wrong rate. Steps 4612-4616 may be performed inconcert with, or in lieu of, steps 4606-4610, in accordance with someembodiments of the present disclosure.

Step 4612 may include the processing equipment calculating the angle foreach index j of the two segments of step 4604, using Eq. 26. Each anglevalue, per index j, is the arctangent of the ratio of the first andsecond segment values, given Eqs. 22 and 23, respectively.

$\begin{matrix}{{Angle}_{j} = {\tan^{- 1}\left( \; \frac{{{Segment}2}_{j}}{{{Segment}1}_{j}} \right)}} & (26)\end{matrix}$

Step 4614 may include the processing equipment calculating the sum ofthe differences between each adjacent angle of step 4612, also referredto as “phase unwrapping”, as shown by Eq. 27:

$\begin{matrix}{{Sum}_{angle} = {\sum\limits_{j = 1}^{N - 1}{\left( {{Angle}_{j} - {Angle}_{j - 1}} \right).}}} & (27)\end{matrix}$

The sum may be approximately proportional to the length of the segments.Segments of length equal to period P should give a sum of roughly 360°,the period P is approximately equal to the characteristic period of thecross-correlation signal. If the cross-correlation exhibits a periodhalf that of period P, then the sum may tend towards 720° for segmentlengths equal to period P. The sum will depend, however, on the lengthof the segments. For example, longer segments (in terms of period P)tend to provide larger sums.

Step 4616 may include the processing equipment comparing the sum of step4614 to one or more threshold values, or range thereof. In someembodiments, the one or more thresholds may include an upper and lowerlimit. In some embodiments, a threshold value may be based on thesegment length. For example, a sum may be compared to a threshold rangeof 300-420°, for segments having a length equal to period P. In afurther example, larger threshold values may be used with segmentshaving a length longer than period P. In some embodiments, for a givensegment length, a threshold value may vary. For example, thresholdvalue(s) may be based on the value of the period P, subject information(e.g., subject history, medical history, medical procedure), whetherinitialization parameters or calculated rates are being qualified, anyother suitable information, or any combination thereof. In someembodiments, the threshold value(s) may be stricter in Search Modeversus Locked Mode. In addition, in some embodiments, the thresholdvalue(s) may be stricter for the first rate calculated in Locked Mode.The stricter threshold(s) may prevent the algorithm from locking ontothe wrong rate.

Step 4618 may include the processing equipment qualifying ordisqualifying the associated initialization parameters, calculated rate,or both, based on the comparison of step 4610, the comparison of step4616, or both. If the ratio, angle sum, or both, exceed the respectivethreshold value, the initialization parameters, calculated rate, orboth, may be disqualified. If the ratio, angle sum, or both, do notexceed the threshold value, the initialization parameters, calculatedrate, or both, may be qualified.

FIG. 47 shows four sets of plots, arranged by row, of (from left toright) illustrative cross-correlation signals and corresponding symmetrycurves, radial curves, radius calculations (top), and angle calculations(bottom), in accordance with some embodiments of the present disclosure.

Plots 4700, 4710, 4720, and 4730 show four respective, illustrativecross-correlation signals, in accordance with some embodiments of thepresent disclosure. The top two cross-correlation signals, of plots 4700and 4710, do not exhibit notches and show relatively consistent periodiccharacter. Plots 4702 and 4712 each show a symmetry curve, with lengthsequal to 1.6 times period P, which corresponds to the cross-correlationsignal of plots 4700 and 4710, respectively. The symmetry curves ofplots 4702 and 4712 show substantially linear character, with respectiveslopes of nearly one, passing roughly through the origin. Accordingly,the peaks of the cross-correlation signals of plots 4700 and 4710 may bedetermined to be relatively symmetric, and an associated initializationparameters, calculated rate, or both, may be qualified based on thesymmetry. Plots 4704 and 4714 each show a radial curve, using segmentlengths equal to period P, which corresponds to the cross-correlationsignal of plots 4700 and 4710, respectively. Plots 4706 and 4708 showrespective radius and angle calculations based on the radial curve ofplot 4704, while plots 4716 and 4718 show respective radius and anglecalculations based on the radial curve of plot 4714. The radial curvesof plots 4704 and 4714 are roughly circular, including a single loop.The radius calculations of plots 4706 and 4716 show some variation, withradius ratios (e.g., calculated using Eq. 25) of 1.18 and 1.54,respectively. The angle calculations of plots 4708 and 4718 give anglesums (e.g., calculated using Eq. 27) of 343.4° and 333.7°, respectively.The symmetry curves and radial curves associated with thecross-correlation results of plots 4700 and 4710, and calculationsthereof, may indicate that the period P provides a relatively goodestimate of the actual physiological period. Accordingly, under somecircumstances, the initialization parameters, calculated rate, or both,associated with period P may be qualified.

The bottom two cross-correlation signals of FIG. 47, of plots 4720 and4730, do not exhibit notches and show relatively consistent periodiccharacter. Plots 4722 and 4732 each show a symmetry curve, with lengthsequal to 1.6 times period P, which corresponds to the cross-correlationoutput of plots 4720 and 4730, respectively. The symmetry curves ofplots 4722 and 4732 show substantially non-linear character, withvarying slopes, and deviating relatively far from the origin. The peaksof the cross-correlation output of plot 4720 show varying amplitude,while the peaks of the cross-correlation signal of plot 4730 show anadditional inflection likely caused by a dicrotic notch in the originalphysiological data. Accordingly, the peaks of the cross-correlationsignals of plots 4720 and 4730 may be determined to be relativelyasymmetric, and an associated initialization parameters, calculatedrate, or both, may be disqualified based on the symmetry. Plots 4724 and4734 each show a radial curve, using segment lengths equal to period P,which correspond to the cross-correlation signal of plots 4720 and 4730,respectively. Plots 4726 and 4728 show respective radius and anglecalculations based on the radial curve of plot 4724, while plots 4736and 4738 show respective radius and angle calculations based on theradial curve of plot 4734. The radial curve of plot 4724 shows two loopsof substantially different radii, indicating that the period P may beroughly twice as long as the actual period of cross-correlation signal4720. The radial curve of plot 4734 shows two non-circular loops, ofvarying radii, indicating that the period P may be roughly twice as longas the actual period of cross-correlation signal 4730. The radiuscalculations of plots 4726 and 4736 show significant variation, withradius ratios (e.g., calculated using Eq. 25) of 3.58 and 6.69,respectively. The angle calculations of plots 4728 and 4738 give anglesums (e.g., calculated using Eq. 27) of 757.6° and 703.9°, respectively.The symmetry curves and radial curves associated with thecross-correlation results of plots 4720 and 4730, and calculationsthereof, may indicate that the period P provides a relatively poorestimate of the actual physiological period. In some embodiments, thismay occur when the rate is locked onto low frequency noise or half thephysiological rate or when the initialization parameters identity lowfrequency noise or half the physiological rate. Accordingly, under somecircumstances, the initialization parameters, calculated rate, or both,associated with period P may be disqualified.

FIG. 48 is a flow diagram 4800 of illustrative steps for qualifying ordisqualifying initialization parameters and/or calculated rates based onareas of positive and negative portions of segments of across-correlation signal, in accordance with some embodiments of thepresent disclosure. In some embodiments, the illustrative steps of flowdiagram 4800 aid in preventing a double-rate (half-period) condition,half-rate (double-period) condition, or other conditions in which periodP is not indicative of a physiological rate. The illustrative steps offlow diagram 4800 may be referred to as the “Area Test.”

Step 4802 may include processing equipment receiving a cross-correlationsignal (e.g., generated according to step 3806 of FIG. 38) as an input.In some embodiments, the cross-correlation signal may be generated by across-correlation module. In some embodiments the cross-correlationsignal may be generated at an earlier time, and stored in suitablememory. Accordingly, in some embodiments, step 4802 may includerecalling the stored cross-correlation signal from the memory. In someembodiments, a single processor, module, or system may perform thecross-correlation and steps 4804-4814, and accordingly, step 4802 neednot be performed.

Step 4804 may include the processing equipment selecting two signalsegments of the cross-correlation signal of step 4802. The first segmentmay be half as large as the second segment. For example, the secondsegment may have a length equal to period P, while the first segment hasa length equal to one half of period P and is included in the secondsegment. In a further example, the second segment may have a lengthequal to period 2P, while the first segment has a length equal to periodP. The two segments may be selected from any suitable portion of thecross-correlation output.

Step 4806 may include the processing equipment calculating the positiveand negative areas of both the first and second segments. Each segmentmay include one or more oscillations, or portions thereof, andaccordingly may include positive and negative portions (e.g., FIGS.49-51 provides further illustration). In some embodiments, step 4806 mayinclude performing a summation of the positive data points, and asummation of the negative data points for each segment. In someembodiments, step 4806 may include performing a piecewise discreteintegration (e.g., a piecewise numerical quadrature or any othersuitable analytical or numerical technique) of the positive and negativeportions of each of the two segments of the cross-correlation signal. Insome embodiments, the area values of step 4806 may both be positivevalues, with the areas of a negative portion of a segment calculated bytaking the absolute value of the integral of the negative portion. Insome embodiments, either or both areas may be normalized by theassociated segment length. This normalization may allow for a particularthreshold to be used for segments having different lengths. For example,the areas of a segment of length P may both be divided by P or one. In afurther example, the areas of a segment of length 2P may both be dividedby 2P or two.

Step 4808 may include the processing equipment determining the absolutevalue of the difference between the positive and negative areas (whichmay both be positive values) for each segment. In some embodiments, theprocessing equipment may calculate the difference between the areas ofthe positive and negative portions of each segment by subtracting thearea of the negative portion, which may be a positive value, from thearea of the positive portion (or vice versa), and then calculating theabsolute value of the difference.

Step 4810 may include the processing equipment repeating steps4804-4808, for various shifts in the segments relative to one another,relative to a varying origin point with the segments' relative positionsfixed, or any other suitable shift. In some embodiments, the first andsecond segments may always originate at the same point, which may beshifted along the cross-correlation output at step 4810 to define thedifferent pairs of segments. In some embodiments, the first segment mayremain fixed and the second segment may be shifted at step 4810. Forexample, the first segment, with a length equal to P/2, may remain fixedand the second segment, with a length equal to P, may be shifted by oneor more degree measures and the difference may be calculated at eachdegree measure. In a further example, the second segment, with a lengthequal to P, may remain fixed and the first segment, with a length equalto P/2, may be shifted by one quarter of the period P, and thedifference may be calculated at this new segment location. Either orboth of the first and second segments may be shifted any suitable amountto generate one or more pairs of first and second segments. In someembodiments, step 4808, step 4810, or both, may include storing the oneor more respective difference values of steps 4808 and 4810 in anysuitable memory, using any suitable data-basing or filing protocol.

Step 4812 may include the processing equipment identifying maximumvalues, minimum values, or both, of the differences among both the firstsegments and the second segments. For example, in some embodiments, theprocessing equipment may identify the maximum difference of the firstsegment(s) and the minimum difference of the second segment(s). In someembodiments, the processing equipment may identify the maximumdifference of the first segment(s) and the minimum difference of thesecond segment(s). Any suitable technique may be used to identify therespective maximum and minimum values. In some embodiments, step 4812may be performed concurrent with steps 4808 and 4810. For example,initial maximum and minimum difference values may be calculated at step4808 and stored. As subsequent difference values are calculated at step4810, the stored values may be replaced as larger or smaller values, asappropriate, are calculated.

Step 4814 may include the processing equipment qualifying ordisqualifying the initialization parameters, calculated rate, or both,based on the identified maximum and minimum differences of step 4812. Insome embodiments, the processing equipment may calculate a differencebetween the maximum difference for the first segments and the minimumdifference for the second segments. For example, one or more thresholdsmay be set based on the value of the minimum difference for the secondsegments (e.g., the threshold value may be equal to the minimumdifference value or a scaling thereof). The maximum difference for thefirst segment may then be compared to the threshold. If the maximumdifference is greater than the threshold, the processing equipment mayqualify the initialization parameters, calculated rate, or both. If themaximum difference is less than the threshold, the processing equipmentmay disqualify the initialization parameters, calculated rate, or both.In some embodiments, the processing equipment may calculate a ratio ofthe maximum difference for the first segment to the minimum differencefor the second segment. For example, one or more thresholds, which maybe predetermined or may depend upon the difference values, may be set.The ratio may then be compared to the threshold. If the ratio is greaterthan the threshold, the processing equipment may qualify theinitialization parameters, calculated rate, or both. If the ratio isless than the threshold, the processing equipment may disqualify theinitialization parameters, calculated rate, or both. In someembodiments, the ratio may be calculated for each pair of first andsecond segments, and a maximum ratio value may be selected to becompared with one or more threshold values. In some embodiments, theareas, differences, or ratios may be normalized by dividing by a valuecorresponding to the segment length. In some embodiments, the thresholdsmay be scaled based on the segment lengths of the period P. In someembodiments, one or more metrics may inputted into a classifier.

In some embodiments, the illustrative steps of flow diagram 4800 may beperformed using segments of length P/2 and P, which may provideparticular benefits under some circumstances. In some embodiments, theillustrative steps of flow diagram 4800 may be performed using segmentsof length P and 2P, which may provide particular benefits under somecircumstances. Any suitable first and second segments may be used toperform the Area Test. The following discussion, referencing FIGS.49-51, provides further detail regarding flow diagram 4800, inaccordance with some embodiments of the present disclosure. The abscissaof each of plots 4900, 5000, and 5100 of FIGS. 49-51, respectively, arepresented in units proportional to cross-correlation lag, while theordinate is presented in arbitrary units, with zero notated.

FIG. 49 is a plot 4900 of an illustrative cross-correlation output 4902,centered about zero with correctly determined initialization parametersor rates, in accordance with some embodiments of the present disclosure.The period P is close to the period exhibited by cross-correlationsignal 4902. As shown in plot 4900, cross-correlation signal 4902 mayinclude portions above the baseline (i.e., values greater than zero),and portions below the baseline (i.e., values less than zero). Dependingon a how a segment of cross-correlation signal 4902 is selected, theareas of the positive and negative portions may change relative to oneanother.

Three illustrative segment lengths are shown in FIG. 49, includingperiod P, one half of period P, and double period P. The difference inthe areas of the positive and negative portions of segments of length Por 2P may be expected to be relatively small for any suitable shiftbecause the segments approximately cover a complete period or doubleperiod exhibited by cross-correlation output 4902. The differencebetween the areas of the positive and negative portions of segments oflength P/2 may be expected to range from small values (e.g., when asegment is centered near a zero of cross-correlation signal 4902) torelatively larger values (e.g., when the segment lies substantiallybetween zeros of cross-correlation signal 4902).

In some cases, in which the initialization parameters or rates arecorrectly determined, a first segment may have a length equal to P/2 andthe second segment may have a length equal to period P. Differences inareas of positive and negative portions of cross-correlation signal 4902may be calculated for multiple first and second segments, havingconstant respective lengths but varying shift. In some such cases, themaximum difference among first segments may be compared to the minimumdifference among second segments, or a threshold derived thereof. Forexample, the maximum difference among first segments may be compared toa threshold equal to four times the minimum difference of the secondsegments. If the maximum difference among first segments is larger thanthe threshold, then the initialization parameters, calculated rate, orboth, may be qualified.

In some cases, in which the initialization parameters or rates arecorrectly determined, a first segment may have a length equal to P andthe second segment may have a length equal to period 2P. Unlike thepreviously discussed cases, in which first and second segments hadrespective lengths of P/2 and P, the differences of the present casesare now both expected to be small values. Accordingly, in some suchcases, the maximum difference among first segments may be compared tothe minimum difference among second segments, or a threshold derivedthereof. For example, the maximum difference among first segments may becompared to a threshold equal to two times the minimum difference of thesecond segments. If the maximum difference among first segments issmaller than the threshold, then the initialization parameters,calculated rate, or both, may be qualified.

FIG. 50 is a plot 5000 of an illustrative cross-correlation output 5002with initialization parameters or rates incorrectly determined to bedouble the correct rate, in accordance with some embodiments of thepresent disclosure. The period P is close to one half of the periodexhibited by cross-correlation signal 5002. Three illustrative segmentlengths are shown in FIG. 50, including period P, one half of period P,and double period P. As illustrated, the difference in the areas of thepositive and negative portions of segments of length 2P may be expectedto be relatively small for any suitable shift. The difference in theareas of the positive and negative portions of segments of lengths P/2or P may be expected to range from small values (e.g., when a segment iscentered near a zero of cross-correlation signal 5002) to relativelylarger values (e.g., when the segment lies substantially between zerosof cross-correlation signal 5002).

In some cases, in which the initialization parameters or rates areincorrectly determined, a first segment may have a length equal to P/2and the second segment may have a length equal to period P. Differencesin areas of positive and negative portions of cross-correlation signal5002 may be calculated for multiple first and second segments, havingconstant respective lengths but varying shift. In some such cases, themaximum difference among first segments may be relatively large comparedto the minimum difference among second segments. Accordingly, under somecircumstances, the use of first and second segments with respectivelengths P/2 and P may allow a double-rate condition to qualify ifsimilar threshold conditions are used as when the initializationparameters or rates are correctly determined.

In some cases, in which the initialization parameters or rates areincorrectly determined, a first segment may have a length equal toperiod P and the second segment may have a length equal to period 2P. Insome such cases, the maximum difference of the first segment may becompared to the minimum difference of the second segment, or a thresholdderived thereof. If the maximum difference among first segments islarger than a suitable threshold (e.g., the same threshold condition asused when the initialization parameters or rates are correctlydetermined), as may be expected, then the initialization parameters,calculated rate, or both, may be disqualified. Accordingly, in someembodiments, the Area Test may provide techniques to disqualify adouble-rate condition.

FIG. 51 is a plot 5100 of an illustrative cross-correlation signal 5102with initialization parameters or rates incorrectly determined to behalf the correct rate, in accordance with some embodiments of thepresent disclosure. The period P is close to twice the period exhibitedby cross-correlation signal 5102. Three illustrative segment lengths areshown in FIG. 51, including period P, one half of period P, and doubleperiod P. As illustrated, the difference in the areas of the positiveand negative portions of segments of lengths P/2, P, and 2P may beexpected to be relatively small for any suitable shift. In some cases,any full period of cross-correlation signal 5102 may provide arelatively low difference value, regardless of shift.

In some cases, in which the initialization parameters or rates areincorrectly determined to be one half the correct rate, a first segmentmay have a length equal to P/2 and the second segment may have a lengthequal to period P. Differences in areas of positive and negativeportions of cross-correlation signal 5102 may be calculated for multiplefirst and second segments, having constant respective lengths butvarying shift. In some such cases, the maximum difference among firstsegments may be comparable to the minimum difference among secondsegments. If the maximum difference among first segments is smaller thanthe threshold (e.g., the same threshold condition as used when theinitialization parameters or rates are correctly determined), then theinitialization parameters, calculated rate, or both, may bedisqualified. Accordingly, the Area Test may provide techniques todisqualify a half-rate condition.

In some cases, in which the initialization parameters or rates areincorrectly determined to be one half the correct rate, a first segmentmay have a length equal to period P and the second segment may have alength equal to period 2P. In some such cases, the maximum difference ofthe first segment may be compared to the minimum difference of thesecond segment, or threshold derived thereof. If the maximum differenceamong first segments is smaller than a suitable threshold (e.g., thesame threshold condition as used when the initialization parameters orrates are correctly determined), as may be expected, then theinitialization parameters, calculated rate, or both, may be qualified.Accordingly, under some circumstances, the use of first and secondsegments with respective lengths P and 2P may allow a half-ratecondition to qualify if similar threshold conditions are used as whenthe initialization parameters or rates are correctly determined.

In view of the foregoing, first and second segments with respectivelengths P/2 and P may prevent qualification of a half-rate condition andfirst and second segment lengths of P and 2P may prevent qualificationof a double-rate condition. Accordingly, in some embodiments, the AreaTest may provide techniques to prevent qualification of double-rate,half-rate, or any other rate condition that is not indicative of aphysiological rate.

FIG. 52 is a plot 5200 of illustrative difference calculations of theArea Test with correctly determined initialization parameters or rates,and a plot 5250 of illustrative calculated rates indicative of an actualphysiological pulse, in accordance with some embodiments of the presentdisclosure. The abscissa of plot 5200 is presented in units of seconds,while the ordinate is presented in arbitrary units, with zero notated.Series 5202 is the maximum difference in first segments, with lengthsequal to one half of period P. Series 5204 is the minimum difference insecond segments, with lengths equal to period P. Threshold 5206 is anillustrative threshold equal to four times series 5204 (i.e., scaledfrom series 5204 by a multiplicative factor of four). As shown in FIG.52, series 5202 lies above threshold 5206, indicating that theinitialization parameters, calculated rate, or both, may be qualified.Plot 5250 of illustrative calculated rates indicative of an actualphysiological rate, in accordance with some embodiments of the presentdisclosure. The abscissa of plot 5250 is presented in units of seconds,while the ordinate is presented in units of BPM. Time series 5252 is thepulse rate (i.e., BPM) as calculated by a subject monitoring systemtracking the actual rate, shown by time series 5254.

FIG. 53 is a flow diagram of illustrative steps for qualifying ordisqualifying initialization parameters and/or calculated rates based ona filtered physiological signal, in accordance with some embodiments ofthe present disclosure. In some embodiments, performance of theillustrative steps of flow diagram 5300 may provide an indication of therelative energy in a high frequency component of a physiological signal.Accordingly, in some circumstances, relatively large amounts of energyat rates much larger than the rate associated with the initializationparameters or a calculated rate may indicate that low-frequency noisehas been locked onto. The illustrative steps of flow diagram 5300 may bereferred to as the “High Frequency Residual Test.”

Step 5302 may include processing equipment receiving at least onephysiological signal from a physiological sensor, memory, any othersuitable source, or any combination thereof. For example, referring tosystem 300 of FIG. 3, processor 312 may receive a physiological signalfrom input signal generator 310. Sensor 318 of input signal generator310 may be coupled to a subject, and may detect physiological activitysuch as, for example, RED and IR light attenuation by tissue, using aphotodetector. In some embodiments, for example, physiological signalsgenerated by input signal generator 310 may be stored in memory (e.g.,memory of system 10 of FIGS. 1-2) after being pre-processed bypre-processor 320. In such cases, step 5302 may include recalling thesignals from the memory for further processing. The physiological signalof step 5302 may include a PPG signal, which may include a sequence ofpulse waves and may exhibit motion artifacts, noise from ambient light,electronic noise, system noise, any other suitable signal component, orany combination thereof. Step 5302 may include receiving a particulartime interval or corresponding number of samples of the physiologicalsignal. In some embodiments, step 5302 may include receiving adigitized, sampled, and pre-processed physiological signal.

Step 5304 may include the processing equipment determining one or moresignal metrics for the physiological signal of step 5302. Signal metricsmay include a standard deviation of the physiological signal, an RMS ofthe physiological signal, an amplitude of the physiological signal, asum or integral of the physiological signal over time or samples, anyother suitable metric indicative of a magnitude of a signal or changethereof, or any combination thereof. In some embodiments, the processingequipment may compute the standard deviation of the physiologicalsignal, which may indicate the relative amplitude of excursions in thesignal about the mean. In a further example, the processing equipmentmay take an absolute value of a physiological signal with zero mean, andthen integrate the resulting signal over time or sample number toprovide an indication of the magnitude of signal excursions about themean (e.g., zero).

Step 5306 may include the processing equipment filtering thephysiological signal of step 5302. In some embodiments, the processingequipment may apply a high-pass filter to the physiological signal ofstep 5302. For example, the processing equipment may apply a high-passfilter (e.g., having any suitable order and spectral characteristics)having a cutoff at double the rate associated with the one or moreinitialization parameters. In some embodiments, the processing equipmentmay apply a notch filter to the physiological signal of step 5302. Forexample, the processing equipment may apply a notch filter (e.g., havingany suitable spectral characteristics) having a notch centered at doublethe rate associated with the one or more initialization parameters. Insome embodiments, the processing equipment may apply a high-pass filterand a notch filter to the physiological signal of step 5302. Forexample, the processing equipment may apply a high-pass filter having acutoff at double the rate associated with the one or more initializationparameters, and a notch filter having a notch centered at double therate associated with the one or more initialization parameters. Theresulting high frequency (HF) signal may be further analyzed at step5308. It will be understood that the physiological signal may undergoadditional filtering before or after step 5306. Accordingly, the“filtered signal” of step 5306 refers to the filtering performed at step5306, and not any previous or subsequent filtering.

Step 5308 may include the processing equipment determining one or moresignal metrics for the filtered signal of step 5306. Signal metrics mayinclude a standard deviation of the filtered signal, an RMS of thefiltered signal, an amplitude of the filtered signal, a sum or integralof the filtered signal over time or samples, any other suitable metricindicative of a magnitude of a signal or change thereof, or anycombination thereof. In some embodiments, the processing equipment maycompute the standard deviation of the filtered signal, which mayindicate the relative amplitude of excursions in the signal about themean. In a further example, the processing equipment may take anabsolute value of a filtered signal with zero mean, and then integratethe resulting signal over time or sample number to provide an indicationof the magnitude of signal excursions about the mean (e.g., zero).

Step 5310 may include the processing equipment comparing the one or moresignal metrics for the physiological signal of step 5302 with the one ormore signal metrics for the filtered signal of step 5306. In someembodiments, the processing equipment may determine a comparison metric.In some embodiments, the processing equipment may determine the ratio ofthe signal metric(s) for the filtered signal to the signal metric(s) forthe physiological signal. For example, the processing equipment maycalculate the ratio of standard deviations of the filtered signal to thephysiological signal. In some embodiments, the processing equipment maydetermine the difference between the signal metric(s) for the filteredsignal and the signal metric(s) for the physiological signal.

Step 5312 may include the processing equipment qualifying ordisqualifying initialization parameters, a calculated rate, or both,based on the comparison of step 5310. In some embodiments, theprocessing equipment may compare the comparison metric of step 5310 withone or more threshold values. For example, the processing equipment maycompare the ratio of standard deviations of the filtered signal to thephysiological signal to a ratio threshold. The ratio threshold may beany suitable fixed or adjustable value. For example, the ratio thresholdmay depend on the initialization parameters. If the ratio is higher thanthe ratio threshold, the processing equipment may disqualify theinitialization parameters. If the ratio is lower than the ratiothreshold, the processing equipment may qualify the initializationparameters. Accordingly, the processing equipment may use the HighFrequency Residual Test to determine conditions having relatively largeamounts of signal energy at rates much larger than the rate associatedwith initialization parameters or a calculated rate.

FIGS. 54 and 55 are illustrative flow diagrams of techniques that mayalso be used to qualify or disqualify initialization parameters, acalculated rate, or both. In some embodiments, the illustrative steps offlow diagrams 5400 and 5500 of FIGS. 54 and 55, respectively, may beperformed based on initialization parameters, a calculated rate, orboth. In some embodiments, the illustrative steps of flow diagrams 5400and 5500 of FIGS. 54 and 55, respectively, may be performed independentof initialization parameters, a calculated rate, or both (e.g., toquantify noise and/or consistency in a buffered signal).

FIG. 54 is a flow diagram 5400 of illustrative steps for qualifying ordisqualifying initialization parameters based on a comparison of areasof two segments of a cross-correlation signal, in accordance with someembodiments of the present disclosure. In some embodiments, performanceof the illustrative steps of flow diagram 5400 may provide an indicationof the similarity between different segments of a cross-correlationsignal. The illustrative steps of flow diagram 5400 may be referred toas the “Area Similarity Test.”

Step 5402 may include processing equipment receiving a cross-correlationsignal (e.g., generated according to step 3806 of FIG. 38) as an input.In some embodiments, the cross-correlation signal may be generated by across-correlation module. In some embodiments the cross-correlationsignal may be generated at an earlier time, and stored in suitablememory. Accordingly, in some embodiments, step 5402 may includerecalling the stored cross-correlation signal from the memory. In someembodiments, a single processor, module, or system may perform thecross-correlation and steps 5404-5408, and accordingly, step 5402 neednot be performed.

Step 5404 may include the processing equipment selecting two segments ofthe cross-correlation signal of step 5402. In some embodiments, the twosegments may be of equal length. In some such embodiments, thecross-correlation signal may be equi-partitioned into a right segmentand a left segment. For example, if the cross-correlation signal is sixseconds in length, the left segment may be the left three seconds andthe right segment may be adjacent right three seconds of the signal. Ina further example, the first and second segments may each have a lengthequal to period P. Any suitable segments may be selected in accordancewith the present disclosure. Note that the two segments will be referredto as Segment1 and Segment2, or the first segment and the secondsegment, although the designations are arbitrarily assigned forillustration purposes (e.g., the first and second segments may beinterchanged in accordance with the present disclosure).

Step 5406 may include the processing equipment calculating the area ofeach of the first and second segments of step 5404. In some embodiments,step 5406 may include calculating an integral (e.g., a quadrature or anyother suitable analytical or numerical technique), sum, or both, of thefirst and second segments. In some embodiments, the calculated area maybe additive among the positive and negative areas. For example, the areaof positive portions and the absolute value of the area of negativeportions may be summed, resulting in a positive result. In someembodiments, the calculated area may be subtractive, in which the areaof positive portions and negative portions of each segment arerespective positive and negative numbers (e.g., integral of the segmentvalues in which negative portions contribute negative integrals), and aresulting sum may be positive or negative.

Step 5408 may include the processing equipment qualifying ordisqualifying initialization parameters, a calculated rate, or both,based on a comparison of the calculated areas of step 5406. Any suitablecomparison technique, including the calculation of any suitablecomparison metric (e.g., difference, ratio), may be used to compare theareas of the two segments. In some embodiments, the processing equipmentmay calculate a difference between the area of the first segment and thearea of the second segment (or vice versa). In some embodiments, theprocessing equipment may calculate a ratio of the area of the firstsegment to the area of the second segment (or vice versa). In someembodiments, qualification or disqualification may include comparing acomparison metric to a threshold value. For example, the differencebetween (or ratio of) the areas of the two segments may be calculatedand if above a threshold value, the initialization parameters,calculated rate, or both, may be disqualified. Using suitable segmentselection, the areas of the two segments may be expected to be similar,if period P provides a relatively accurate indication of a physiologicalpulse period.

In some embodiments, step 5408 need not be performed with steps5402-5406. In some embodiments, steps 5402-5406 may be performedindependent of initialization parameters or a calculated rate. Forexample, a cross-correlation signal of a buffered window of data may beanalyzed using steps 5402-5406. The areas of two segments (e.g., fixedlength segments) of the cross-correlation signal may be compared using acomparison metric, and under some circumstances the buffered data may bequalified or disqualified (e.g., based on a comparison of the comparisonmetric with a threshold). This may be particularly useful when thephysiological signal is relatively noise free and then noise suddenlyappears in the signal. This may also be particularly useful when strongnon-periodic noise is present in the signal.

FIG. 55 is a flow diagram 5500 of illustrative steps for qualifying ordisqualifying initialization parameters based on statistical propertiesof a cross-correlation signal, in accordance with some embodiments ofthe present disclosure. In some embodiments, performance of theillustrative steps of flow diagram 5500 may provide an indication of thesimilarity between positive and negative portions of a cross-correlationsignal. The illustrative steps of flow diagram 5500 may be referred toas the “Statistical Property Test.”

Step 5502 may include processing equipment receiving a cross-correlationsignal (e.g., generated according to step 3806 of FIG. 38) as an input.In some embodiments, the cross-correlation signal may be generated by across-correlation module. In some embodiments the cross-correlationsignal may be generated at an earlier time, and stored in suitablememory. Accordingly, in some embodiments, step 5502 may includerecalling the stored cross-correlation signal from the memory. In someembodiments, a single processor, module, or system may perform thecross-correlation and steps 5504-5508, and accordingly, step 5502 neednot be performed.

Step 5504 may include the processing equipment selecting the positivevalues of the cross-correlation signal, and selecting the negativevalues of the cross-correlation signal. For example, the processingequipment may compare each value of the cross-correlation signal tozero, and use the comparison to select positive and/or negative values.

Step 5506 may include the processing equipment calculating a statisticalproperty of the positive values and of the negative values of step 5504.The statistical property may include a mean, standard deviation,variance, root-mean-square (RMS) deviation (e.g., relative to zero), anyother suitable statistical property, or any combination thereof. In someembodiments, the positive values and negative values may be processedseparately at step 5506.

Step 5508 may include the processing equipment qualifying ordisqualifying initialization parameters, a calculated rate, or both,based on a comparison of the statistical properties of step 5506. Anysuitable comparison technique, including the calculation of any suitablecomparison metric (e.g., difference, ratio), may be used to compare thestatistical properties of the positive and negative values. In someembodiments, the processing equipment may calculate a difference betweenthe statistical properties of the positive and negative values (or viceversa). In some embodiments, the processing equipment may calculate aratio of the statistical properties of the positive and negative values(or vice versa). In some embodiments, qualification or disqualificationmay include comparing a comparison metric to a threshold value. Forexample, the difference between (or ratio of) the statistical propertiesof the positive and negative values may be calculated and if above athreshold value, the initialization parameters, calculated rate, orboth, may be disqualified.

In some embodiments, step 5508 need not be performed with steps5502-5506. In some embodiments, steps 5502-5506 may be performedindependent of initialization parameters or a calculated rate. Forexample, a cross-correlation signal of a buffered window of data may beanalyzed using steps 5502-5506. The statistical properties of thepositive and negative values of the cross-correlation output may becompared using a comparison metric, and under some circumstances thebuffered data may be qualified or disqualified (e.g., based on acomparison of the comparison metric with a threshold).

In some embodiments, the illustrative steps of flow diagrams 5600 and5700 of FIGS. 56 and 57, respectively, may be performed to qualify ordisqualify initialization parameters, a calculated rate, or both. Insome embodiments, the illustrative analyses of flow diagrams 5600 and5700 of FIGS. 56 and 57, respectively, may be performed to increaseconfidence in a qualified rate. In some embodiments, flow diagrams 5600and 5700 of FIGS. 56 and 57, respectively, may use a combination of anyor all of the previously discussed qualification techniques. Forexample, the steps of flow diagrams 5600 and 5700 may be performed tofurther investigate whether initialization parameters and calculatedrates correspond to a physiological rate of interest (e.g., pulse rate)by using multiple types of templates, multiple lengths of templates, orboth.

FIG. 56 is a flow diagram 5600 of illustrative steps for analyzingqualification metrics based on scaled templates of different lengths, inaccordance with some embodiments of the present disclosure. In someembodiments, performance of the illustrative steps of flow diagram 5600may provide an evaluation of the qualification, or disqualification, ofinitialization parameters, a calculated rate, or both. The illustrativesteps of flow diagram 5600 may be referred to as “QualificationAnalysis.”

Step 5602 may include processing equipment receiving an initializationparameter, previously calculated rate, any other suitable qualificationinformation, or any combination thereof. In some embodiments, step 5602may include recalling the stored initialization parameter, previouslycalculated rate, or both, from suitable memory. In some embodiments, asingle processor, module, or system may calculate, store, or both,initialization parameters and the previously calculated rate, andperform steps 5604-5608, and accordingly, step 5602 need not beperformed.

Step 5604 may include the processing equipment computing one or morequalification metrics based on a template scaled to a first length. Insome embodiments, the scaled template may be used to generate across-correlation signal (e.g., using any suitable steps of flow diagram3800 of FIG. 38), which may be analyzed according to any of theQualification Techniques. In some embodiments, step 5604 may includeperforming a Symmetry Test, performing a Radius Test, performing anAngle Test, performing an Area Test, performing an Area Similarity Test,performing a Statistical Property Test, performing a High FrequencyResidual Test, performing any other suitable test, performing anyportions thereof, or any combination thereof. For example, aqualification metric may include a variability metric (e.g., calculatedusing Eq. 20a or 20b), a radius value (e.g., calculated using Eq. 25),and angle sum value (e.g., calculated using Eq. 27), an area of asegment, a statistical property, any other suitable metric, any metricderived thereof, or any combination thereof.

Step 5606 may include the processing equipment computing one or morequalification metrics based on a template scaled to a particular lengthdifferent than the length of step 5604. In some embodiments, step 5606may include performing a Symmetry Test, performing a Radius Test,performing an Angle Test, performing an Area Test, performing an AreaSimilarity Test, performing a Statistical Property Test, performing aHigh Frequency Residual Test, performing any other suitable test,performing any portions thereof, or any combination thereof. Step 5606may be performed any suitable number of times with templates ofdifferent lengths, as indicated by the ellipsis of flow diagram 5600.

In some embodiments, using templates scaled to different lengths atsteps 5604-5606 may aid in determining whether the initializationparameters, calculated rate, or both, are the true physiological rate.In some embodiments, a template may be scaled to a first length, basedon the calculated rate or associated period (e.g., scaled to one half,one third, or double the rate). In some embodiments, the scaling usedmay be based on the calculated rate, initialization parameters, or both.In a further example, a template may be scaled based on a noisecomponent. For example, if the calculated rate is 50 BPM, a templateneed not be scaled to the half-rate because 25 BPM is an unlikelyphysiological pulse rate. For relatively lower rates, templates scaledto higher rates may be used to determine if the initializationparameters or calculated rates are locked onto low-frequency noise. In afurther example, for higher rates (e.g., 90 BPM and above) a templatemay be scaled to one half, one third, or other fraction of thecalculated rate to determine if the initialization parameters orcalculated rates are locked onto a harmonic of the physiological rate.

Step 5608 may include the processing equipment analyzing thequalification metrics of steps 5604 and 5606 to determine whether toqualify or disqualify the initialization parameter, previouslycalculated rate, or both, of step 5602. For example, the Angle Test maygive a calculated angle sum of about 700° when a template is scaled tothe calculated rate. If the Angle Test gives a calculated angle sum ofabout 360° when a template is scaled to one half of the periodcorresponding to the calculated rate, then the processing equipment maydetermine that there is a half-rate condition, and accordingly mayqualify the half-rate and/or disqualify the rate. In a further example,two templates of the same length may be used at steps 5604 and 5606, onehaving a dicrotic notch and the other having no dicrotic notch. If theprocessing equipment qualifies at least one of the two templates, thenthe initialization parameters, calculated rate, or both, may bequalified.

FIG. 57 is a flow diagram 5700 of illustrative steps for selecting oneor more templates, and analyzing qualification metrics based on scaledtemplates, in accordance with some embodiments of the presentdisclosure. In some embodiments, performance of the illustrative stepsof flow diagram 5700 may provide an evaluation of the qualification, ordisqualification, of initialization parameters, a calculated rate, orboth.

Step 5702 may include processing equipment receiving an initializationparameter, previously calculated rate, any other suitable qualificationinformation, or any combination thereof. In some embodiments, step 5702may include recalling the stored initialization parameter, previouslycalculated rate, or both, from suitable memory. In some embodiments, asingle processor, module, or system may calculate, store, or both,initialization parameters and the previously calculated rate, andperform steps 5704-5710, and accordingly, step 5702 need not beperformed.

Step 5704 may include the processing equipment selecting one or moretemplates based on the qualification information of step 5702. In someembodiments, a variety of template shapes may be available to theprocessing equipment (e.g., stored in suitable memory accessible to theprocessing equipment). For example, some templates may exhibit adicrotic notch while others do not exhibit a dicrotic notch. In afurther example, some templates may exhibit symmetric peaks, whileothers do not exhibit symmetric peaks. In some embodiments, the templatetype may depend on a representative rate or period, which may beassociated with initialization parameters, a calculated rate, or both.For example, in some embodiments, the processing equipment may selectthe one or more templates depending on the value of period P. Forexample, at relatively lower values of period P, a relatively moresymmetrical template, without a dicrotic notch, may be selected. In someembodiments, a predefined number of templates may be used (e.g., alltemplates are always used), and accordingly, the selection of step 5704need not be performed.

Step 5706 may include the processing equipment scaling a first template,of the one or more templates of step 5704, and calculating one or morequalification metrics based on the scaled first template. In someembodiments, the scaled first template may be used to generate across-correlation signal (e.g., using any suitable steps of flow diagram3800 of FIG. 38), which may be analyzed according to any of theQualification Techniques. In some embodiments, step 5706 may includeperforming a Symmetry Test, performing a Radius Test, performing anAngle Test, performing an Area Test, performing an Area Similarity Test,performing a Statistical Property Test, performing a High FrequencyResidual Test, performing any other suitable test, performing anyportions thereof, or any combination thereof.

Step 5708 may include the processing equipment scaling a secondtemplate, of the one or more templates of step 5704, and calculating oneor more qualification metrics based on the scaled second template. Insome embodiments, the scaled second template may be used to generate across-correlation signal (e.g., using any suitable steps of flow diagram3800 of FIG. 38), which may be analyzed according to any of theQualification Techniques. In some embodiments, step 5708 may includeperforming a Symmetry Test, performing a Radius Test, performing anAngle Test, performing an Area Test, performing an Area Similarity Test,performing a Statistical Property Test, performing a High FrequencyResidual Test, performing any other suitable test, performing anyportions thereof, or any combination thereof. Step 5708 may be performedany suitable number of times with different template shapes, asindicated by the ellipsis of flow diagram 5700.

Step 5710 may include the processing equipment analyzing thequantification metrics of steps 5706 and 5708 to determine whether toqualify or disqualify initialization parameters, a calculated rate, orboth. The use of templates having different shapes may allow for moreconfidence in the results of a qualification. For example, if acalculated rate is 120 BPM or higher, then a symmetric template may beused. Further, if the calculated rate is below 120 BPM, then fourtemplates may be used (e.g., symmetric and asymmetric, both with andwithout a dicrotic notch) to determine which template provides the bestresults during qualification.

In some embodiments, any or all of the illustrative steps of flowdiagrams 5600 and 5700 may be suitably combined. The illustrative stepsof flow diagrams 5600 and 5700 may be performed sequentially,simultaneously, alternately, or any other suitable combination. In someembodiments, variation in both the length and shape of a template may beused to aid in qualifying or disqualifying initialization parameters, acalculated rate, or both. In some embodiments, the shape of a templatemay depend on the length of the template. For example, templates ofshorter length (i.e., shorter period), may exhibit more symmetry thantemplates of longer length. In some embodiments, a set of templates maybe used, which each may have a particular length and shape. For example,a coarse set of templates (e.g., spanning a relatively large range oflengths, shapes, or both) may be used initially to determine a region ofinterest among the lengths and shapes (e.g., which templates provide thebest result). A more refined set of templates, selected based on theregion of interest, may then be used to calculate the rate with moreaccuracy, confidence, or both.

It will be understood that the Qualification Techniques disclosed hereinare merely illustrative and any suitable variations may be implementedin accordance with the present disclosure. In some embodiments, theQualification Techniques may be performed on signals other thancross-correlation signals. For example, the Qualification Techniques maybe performed on any suitable physiological signal or any suitable signalderived thereof, such as a raw intensity signal, a conditioned intensitysignal, and an autocorrelation signal. In some embodiments, it may bedesired that the signal used in the Qualification Techniques includes aperiodic component that corresponds to a physiological rate.

It will be understood that the templates used in the QualificationTechniques need not be scaled. In some embodiments, a library oftemplates may be stored in memory and accessible by the processingequipment. For each template, the library may store a complete range ofdesired template lengths (e.g., lengths corresponding to the range of20-300 BPM, with a resolution of 1 BPM). Therefore, instead of scaling atemplate, the processing equipment may select a template with a desiredlength from the library. Regardless of how the template is selected orgenerated, the template may be referred to herein as a “referencewaveform.”

Any suitable variation of Search Mode may be implemented in accordancewith the present disclosure. Several illustrative examples are providedand discussed in the context of FIGS. 58-60.

FIG. 58 is a flow diagram 5800 of illustrative steps for determiningwhether to change the Search Technique or to transition from Search Modeto Locked Mode, in accordance with some embodiments of the presentdisclosure. In some embodiments, the illustrative steps of flow diagram5800 may aid in preventing continual (e.g., repeated) disqualificationof initialization parameters determined during Search Mode (e.g., byadjusting conditioning, processing, or both, of the signal).

Step 5802 may include processing equipment, pre-processor 320, or both,performing signal conditioning on at least one physiological signal.Signal conditioning may include filtering (e.g., low pass, high pass,band pass, notch, or any other suitable filter), amplifying, performingan operation on the received signal (e.g., taking a derivative,averaging), performing any other suitable signal conditioning, or anycombination thereof. For example, in some embodiments, step 5802 mayinclude removing a DC offset, low frequency components, or both, of thereceived physiological signal. In a further example, step 5802 mayinclude smoothing the received physiological signal (e.g., using amoving average or other smoothing technique).

Step 5804 may include the processing equipment determining one or moreinitialization parameters. Step 5804 may be used by the processingequipment to estimate characteristics of the received physiologicalsignal such as, for example, physiological rates, periods, or likelyranges thereof. In some embodiments, initialization parameters mayinclude one or more settings of a band pass filter such as, for example,a high and low frequency cutoff value (e.g., a frequency range), arepresentative frequency value (or period value), a set of one or morecoefficients, any other suitable parameters, or any combination thereof.The initialization parameters may be determined based on thephysiological signal of step 5802. Any suitable Search Mode techniquesdisclosed herein, combinations thereof, or portions thereof, may be usedat step 5804.

Step 5806 may include the processing equipment qualifying the one ormore determined initialization parameters of step 5804, while step 5808may include the processing equipment determining whether thequalification of step 5806 is sufficient. Step 5806 may includecalculating one or more qualification metrics indicative of an estimatedquality or accuracy of the determined initialization parameters. Forexample, a particular initialization parameter may be determined at step5804, using any suitable Search Technique of the present disclosure. Theparticular initialization parameters may be evaluated, and if it isdetermined that the parameters do not qualify at step 5808, then theprocessing equipment may continue on to step 5812. If it is determinedthat the parameters do qualify at step 5808, then the processingequipment may proceed to performing a rate calculation at step 5810.

Step 5810 may include the processing equipment proceeding to performingrate calculation in Locked Mode using the initialization parametersdetermined at step 5804. Any suitable rate calculation techniquedisclosed herein, combination thereof, or portion thereof, may be usedat step 5810.

Step 5812 may include the processing equipment storing one or moreinitialization parameters, qualification failure information, any othersuitable information, or any combination thereof in any suitable memory.In some embodiments, for a particular initialization parameter,qualification failure information such as failure type maybe stored andcatalogued, providing a historical record of failures.

Step 5814 may include the processing equipment analyzing the storedinformation of step 5812 (e.g., initialization parameters, qualificationfailure information). Analysis of the stored information may includereviewing a historical record of failures to identify a pattern,analyzing the results of other qualification tests, any other suitableanalysis, or any combination thereof.

Step 5816 may include the processing equipment modifying, changing, orboth, the Search Technique used to determine initialization parameters,the signal conditioning of the physiological signal, or any othersuitable processes of Search Mode. Following performance of step 5816,steps 5802-5808 may be repeated to determine whether to proceed toperforming the rate calculation.

In an illustrative example, referencing flow diagram 5800, qualificationmay repeatedly fail (i.e., repeated disqualification) due to lockingonto of low frequency noise (e.g., in the case of a neonate).Illustratively, the low frequency noise may have a component in the40-60 BPM range. In some such cases, especially in the case of neonates,step 5816 may include adjusting the signal conditioning of step 5802 toinclude a high-pass filter (e.g., with a cutoff point of 90 BPM) toeffectively remove the lower-frequency components when repeated failuresoccur for initialization parameters corresponding to low BPM rates.

In a further illustrative example, referencing flow diagram 5800, aninitialization parameter may correspond to a rate greater than 80 BPM,and the Angle Test may repeatedly output an angle sum of around 720°,causing disqualification. In some such cases, especially in the case ofsubjects with dicrotic notches, step 5816 may include adjusting thesignal conditioning of step 5802 to include a notch filter (e.g.,centered at the rate that repeatedly fails) to effectively remove orattenuate the dicrotic notch.

In a further illustrative example, referencing flow diagram 5800, theuse of a cross-correlation waveform, cross-correlation output, or both,may be modified at step 5816. In some embodiments, only some segments ofa cross-correlation waveform may be used (e.g., low-rate, high-rate, orany other particular segments may be omitted). In some embodiments, onlysome segments of a cross-correlation output may be analyzed (e.g.,low-rate, high-rate, or any other particular segments may be ignored).In some embodiments, amplitudes of pulses within particular segments ofa cross-correlation waveform may be adjusted, to change the likelihoodof a maximum occurring within those particular segments. For example,the amplitude of pulses of a particular segment may be reduced to reducethe likelihood of a maximum amplitude occurring in that particularsegment.

FIG. 59 is a flow diagram 5900 of illustrative steps for determiningwhether to transition from Search Mode to Locked Mode, in accordancewith some embodiments of the present disclosure. In some embodiments,the illustrative steps of flow diagram 5900 may aid in preventing arepeated lock onto a rate other than a desired physiological rate (e.g.,preventing locking on noise rather than a pulse rate).

Step 5902 may include processing equipment, pre-processor 320, or both,performing signal conditioning on at least one physiological signal.Signal conditioning may include filtering (e.g., low pass, high pass,band pass, notch, or any other suitable filter), amplifying, performingan operation on the received signal (e.g., taking a derivative,averaging), performing any other suitable signal conditioning, or anycombination thereof. For example, in some embodiments, step 5902 mayinclude removing a DC offset, low frequency components, or both, of thereceived physiological signal. In a further example, step 5902 mayinclude smoothing the received physiological signal (e.g., using amoving average or other smoothing technique).

Step 5904 may include the processing equipment determining one or moreinitialization parameters. Step 5904 may be used by the processingequipment to estimate characteristics of the received physiologicalsignal such as, for example, physiological rates, periods, or likelyranges thereof. In some embodiments, initialization parameters mayinclude one or more settings of a band pass filter such as, for example,a high and low frequency cutoff value (e.g., a frequency range), arepresentative frequency value (or period value), a set of one or morecoefficients, any other suitable parameters, or any combination thereof.The initialization parameters may be determined based on thephysiological signal of step 5902. Any suitable Search Techniquesdisclosed herein, combinations thereof, or portions thereof, may be usedat step 5904.

Step 5906 may include the processing equipment qualifying the one ormore determined initialization parameters of step 5904, while step 5908may include the processing equipment determining whether thequalification of step 5906 is sufficient. Step 5906 may includecalculating one or more qualification metrics indicative of an estimatedquality or accuracy of the determined initialization parameters. Forexample, a particular initialization parameter may be determined at step5904, using any suitable Search Technique of the present disclosure. Theparticular initialization parameters may be evaluated, and if it isdetermined that the parameters do not qualify at step 5908, then theprocessing equipment may continue on to step 5912. If it is determinedthat the parameters do qualify at step 5908, then the processingequipment may proceed to performing a rate calculation at step 5910.

Step 5910 may include the processing equipment proceeding to performinga rate calculation in Locked Mode using the initialization parametersdetermined at step 5904. Any suitable Rate Calculation Techniquedisclosed herein, combination thereof, or portion thereof, may be usedat step 5910.

Step 5912 may include the processing equipment storing one or moreinitialization parameters, qualification failure information, any othersuitable information, or any combination thereof in any suitable memory.In some embodiments, for a particular initialization parameter,qualification failure information such as failure type maybe stored andcatalogued, providing a historical record of failures.

Step 5914 may include the processing equipment analyzing the storedinformation of step 5912 (e.g., initialization parameters, qualificationfailure information). Analysis of the stored information may includereviewing a historical record of failures to identify a pattern,analyzing the results of other Qualification tests, any other suitableanalysis, or any combination thereof.

Step 5916 may include the processing equipment determining whether oneor more failure conditions have been met, based on the analysis of step5914. If the processing equipment determines that one or more failureconditions have been met, the processing equipment then may proceed tostep 5918. If the processing equipment determines that one or morefailure conditions have not been met, the processing equipment then mayproceed back to step 5902. In some embodiments, failure conditions mayinclude particular results of particular tests. For example, the resultof the Angle Test may be used to determine if one or more initializationparameters correspond to a half-rate condition.

Step 5918 may include the processing equipment modifying the one or moreinitialization parameters of step 5904. Step 5918 may include theprocessing equipment modifying the initialization parameter (e.g., arate or range of rates) by a multiple (e.g., doubling or halving therate) based on the analysis of step 5914. For example, the processingequipment may determine that initialization parameter(s) are indicativeof a harmonic of the physiological rate at step 5914, and may modify theinitialization parameter(s) to correspond to a fundamental frequency ofthe physiological rate at step 5918.

In an illustrative example, referencing flow diagram 5900, theprocessing equipment may consistently lock onto a one half, double,triple, or other multiple of the true physiological rate. If theinitialization parameter corresponds to 50 BPM, and the Angle Testrepeatedly outputs about 720°, step 5918 may include setting theinitialization parameter to correspond to 100 BPM (i.e., doubling therate, halving the period) and proceeding to a Rate CalculationTechnique.

FIG. 60 is a flow diagram 6000 of illustrative steps for determiningwhether to transition from Search Mode to Locked Mode using multipletechniques, in accordance with some embodiments of the presentdisclosure. In some embodiments, the illustrative steps of flow diagram6000 may aid in determining a physiological rate by using more than onetechnique to condition a physiological signal, search for initializationparameters, qualify initialization parameters, or combinations thereof.In some embodiments, the use of multiple techniques may increaseaccuracy, confidence, or both of initialization parameters. In someembodiments, the use of multiple techniques may address any weaknessesin any single technique and accordingly provide a more robustcalculation.

Step 6002 may include processing equipment, pre-processor 320, or both,performing signal conditioning on at least one physiological signal.Signal conditioning may include filtering (e.g., low pass, high pass,band pass, notch, or any other suitable filter), amplifying, performingan operation on the received signal (e.g., taking a derivative,averaging), performing any other suitable signal conditioning, or anycombination thereof. For example, in some embodiments, step 6002 mayinclude removing a DC offset, low frequency components, or both, of thereceived physiological signal. In a further example, step 6002 mayinclude smoothing the received physiological signal (e.g., using amoving average or other smoothing technique).

Step 6004 may include the processing equipment determining one or moreinitialization parameters, or other algorithm settings (e.g., such asthose used to generate a threshold), using a particular SearchTechnique. Step 6004 may be used by the processing equipment to estimatecharacteristics of the received physiological signal such as, forexample, physiological rates, periods, or likely ranges thereof. In someembodiments, initialization parameters may include one or more settingsof a band pass filter such as, for example, a high and low frequencycutoff value (e.g., a frequency range), a representative frequency value(or period value), a set of one or more coefficients, any other suitableparameters, or any combination thereof. The initialization parametersmay be determined based on the physiological signal of step 6002. Anysuitable Search Techniques disclosed herein (e.g., Search Techniques 1,2, 3, or 4), combinations thereof, or portions thereof, may be used atstep 6004.

Step 6006 may include the processing equipment, pre-processor 320, orboth, performing signal conditioning on the same at least onephysiological signal of step 6002. Signal conditioning may includefiltering (e.g., low pass, high pass, band pass, notch, or any othersuitable filter), amplifying, performing an operation on the receivedsignal (e.g., taking a derivative, averaging), performing any othersuitable signal conditioning, or any combination thereof. For example,in some embodiments, step 6006 may include removing a DC offset, lowfrequency components, or both, of the received physiological signal. Ina further example, step 6006 may include smoothing the receivedphysiological signal (e.g., using a moving average or other smoothingtechnique).

In some embodiments, step 6006 may include different signal conditioningtechniques than those used at step 6002. For example, step 6002 mayinclude applying a low-pass filter to the physiological signal, whilestep 6006 may include applying a high-pass filter to the physiologicalsignal. In a further example, step 6002 may include removing 60 Hznoise, 50 Hz noise, and harmonics using band-stop filters or notchfilters, while step 6006 may include applying a low-pass filter toremove high-frequency noise. Although only two signal conditioning stepsare shown in flow diagram 6000, any suitable number of signalconditioning steps may be performed, as indicated by the ellipsis.

Step 6008 may include the processing equipment determining one or moreinitialization parameters, or other algorithm settings (e.g., such asthose used to generate a threshold), using a particular SearchTechnique. Step 6008 may be used by the processing equipment to estimatecharacteristics of the received physiological signal such as, forexample, physiological rates, periods, or likely ranges thereof. In someembodiments, initialization parameters may include one or more settingsof a band pass filter such as, for example, a high and low frequencycutoff value (e.g., a frequency range), a representative frequency value(or period value), a set of one or more coefficients, any other suitableparameters, or any combination thereof. The initialization parametersmay be determined based on the physiological signal of step 6006. Anysuitable Search Techniques disclosed herein (e.g., Search Technique 1,2, 3, or 4), combinations thereof, or portions thereof, may be used atstep 6008.

In some embodiments, step 6008 may include the same Search Techniqueused at step 6004. For example, step 6004 may include performing SearchTechnique 4, in which a cross-correlation output is analyzed, while step6008 may also include performing Search Technique 4 (e.g., with adifferent cross-correlation waveform than step 6004), in which across-correlation output is analyzed.

In some embodiments, step 6008 may include a different Search Techniquethan that used at step 6004. For example, step 6004 may includeperforming Search Technique 1, in which peak crossings are analyzed,while step 6008 may include performing Search Technique 2, in which peakshapes are analyzed. In some embodiments, the Search Technique used maydepend on the signal conditioning technique used, and vice versa. Forexample, if Search Technique 2 is performed at step 6004, step 6008, orboth, a respective high-pass filter may be used to reduce or eliminatelow-frequency noise that would likely affect peak shape.

In some embodiments, steps 6004 and 6008 may be performed sequentially.In some embodiments, depending upon the result of step 6004, step 6008may, but need not, be performed. In some embodiments, steps 6004 and6008 may be performed in parallel (e.g., simultaneously or nearsimultaneously). Although only two initialization parameterdetermination steps are shown in flow diagram 6000, any suitable numberof initialization parameter determination steps may be performed, asindicated by the ellipsis.

Step 6010 may include the processing equipment analyzing theinitialization parameters (e.g., corresponding rates), or otheralgorithm settings, resulting from the determinations (e.g., Searches)of steps 6004 and 6008. In some embodiments, the analysis of step 6010may include combining the initialization parameters of steps 6004 and6008. For example, at step 6010, the initialization parameters of steps6004 and 6008 may be averaged with or without adjustable weighting. In afurther example, at step 6010, the initialization parameters of steps6004 and 6008 may be input into a histogram (e.g., with historicalresults, or results from additional determinations) and theinitialization parameters, or range thereof, exhibiting the maximumoccurrence may be selected. In a further example, at step 6010, theaverage and standard deviation of the initialization parameters of steps6004 and 6008 may be calculated. If the standard deviation is too largerelative to the average (e.g., as compared to a threshold), step 6010may require that any or all of steps 6002-6008 be repeated. In someembodiments, the analysis of step 6010 may include disregarding one ormore initialization parameters. For example, at step 6010, theinitialization parameters of steps 6004 and 6008 may be averaged withoutoutliers (e.g., initialization parameters outside of a particular numberof standard deviations from the mean).

In some embodiments, the initialization parameters of both step 6004 and6008 may be analyzed at step 6010, and both may be subjected toQualification following step 6010. For example, both steps 6004 and 6008may result in initialization parameters that may be subjected toqualification at steps 6012 or 6014, and step 6010 need not beperformed. In some embodiments, during the analysis of step 6010, noneof the initialization parameters may be subjected to Qualification, andthe process may end at step 6010, or may repeat (not shown) beginning atany of steps 6002-6008.

Step 6012 may include the processing equipment qualifying (ordisqualifying) a first set of one or more initialization parameters, orother algorithm settings, using any suitable Qualification Technique. Insome embodiments, step 6012 may include performing a Symmetry Test,performing a Radius Test, performing an Angle Test, performing an AreaTest, performing an Area Similarity Test, performing a StatisticalProperty Test, performing any other suitable analysis, performing anyportions thereof, or any combination thereof. In some embodiments, theoutput of step 6012 may be one or more qualification metrics (e.g., aradius calculation, an angle sum calculation, cross-correlation area, orother suitable metric or combination thereof)

Step 6014 may include the processing equipment qualifying (ordisqualifying) an Nth set of one or more initialization parameters, orother algorithm settings, using any suitable Qualification Technique. Insome embodiments, the qualification of step 6014 may be of the same typeas the qualification of step 6012. For example, both steps 6012 and 6014may include performing an Area Test. In some embodiments, thequalification of step 6014 may be of a different type than thequalification of step 6012. For example, step 6012 may includeperforming a Radius Test and an Angle Test, while step 6014 may includeperforming a Statistical Property Test.

In some embodiments, the qualifications of steps 6012 and 6014 may beperformed using the same qualification information (e.g., initializationparameters, calculated rate), different initialization parameters, orany combination thereof. For example, both steps 6012 and 6014 mayinclude performing a Symmetry Test, each using a particular period Passociated with initialization parameters from steps 6004 and 6008. Anysuitable number of sets of one or more initialization parameters may bequalified (or disqualified) at steps 6012 and 6014.

In some embodiments, steps 6012 and 6014 may be performed sequentially.In some embodiments, depending upon the result of step 6012, step 6014may, but need not, be performed. In some embodiments, steps 6012 and6014 may be performed in parallel (e.g., simultaneously). Although onlytwo qualification steps are shown in flow diagram 6000, any suitablenumber of qualification steps may be performed, as indicated by theellipsis.

Step 6016 may include the processing equipment analyzing thequalifications and/or disqualifications of steps 6012 and 6014. In somecases, steps 6012 and 6014 may give conflicting results such as, forexample, step 6012 may qualify an initialization parameter while 6014may disqualify the initialization parameter. In some cases, steps 6012and 6014 may both qualify respective initialization parameters. In someembodiments, the analysis of step 6016 may include determining whetherthe respective qualified initialization parameters of steps 6012 and6014 are the same, and how to proceed. For example, if the qualifiedinitialization parameters are the same, and are not an unreasonable(e.g., outside of expected ranges), step 6016 may output the qualifiedinitialization parameters to step 6018. In some cases, only someinitialization parameters may be qualified. In some embodiments, theprocessing equipment may determine a resulting algorithm setting (e.g.,initialization parameters), based on whether the algorithm settings ofstep 6012 and 6014 are qualified. For example, if two algorithm settingsare qualified at respective steps 6012 and 6014, the processingequipment may combine the two algorithm settings.

Step 6018 may include the processing equipment determining whether thequalification of steps 6012 and 6014 are sufficient based on theanalysis of step 6016. Steps 6012-6016 may include calculating one ormore qualification metrics indicative of an estimated quality oraccuracy of the determined initialization parameters. For example, aparticular initialization parameter may be determined at steps 6004 and6008, using any suitable Search Technique(s) of the present disclosure.The particular initialization parameters may be evaluated, and if it isdetermined that the parameters do not qualify at steps 6012 and 6014,then the processing equipment may repeat any of the steps of flowdiagram 6000 (e.g., steps 6002-6016), wait for the next window of datato be buffered (e.g., to partially or fully replace the current windowof data), or both. If it is determined that the parameters do qualify atstep 5908, then the processing equipment may proceed to performing arate calculation at step 6020.

Step 6020 may include the processing equipment proceeding to performinga rate calculation in Locked Mode using the initialization parametersdetermined at steps 6004 and 6008. Any suitable Rate CalculationTechnique disclosed herein, combination thereof, or portion thereof, maybe used at step 6020.

In some embodiments, the processing equipment may combine metrics,qualifications/disqualifications, any other suitable information, or anycombination thereof in a neural network to determine which Technique maybe desired under some circumstances. In some embodiments, for example,as system 300 processes data over time, the processing equipment may usea neural network to adapt the Techniques and parameters thereof used bythe processing equipment to determine physiological information of asubject. For example, as initialization parameters are qualified and/ordisqualified at step 6018, the processing equipment may adjust orotherwise update thresholds, criterion, or analysis techniques to selectinitialization parameters having higher probabilities of beingqualified.

In some embodiments, the processing equipment may evaluate metricmagnitudes, margins by which a test is passed or failed, any othersuitable information, or any combination thereof, to determine how toproceed. In some embodiments, as one or more Qualification Techniquesare applied to the initialization parameters of steps 6004 and 6008, theprocessing equipment may compare results. For example, if steps 6004 and6008 output different initialization parameters that are both qualifiedat step 6016, the processing equipment may evaluate whether one set ofinitialization parameters passed a particular test by a relativelyhigher margin. Accordingly, the processing equipment may select theinitialization parameters passing a qualification test by the highestmargin to use in a rate calculation.

In some embodiments, signal conditioning may be applied to aphysiological signal to aid in processing the signal for rateinformation. As described above, signal conditioning may includefiltering, de-trending, smoothing, any other suitable conditioning, orany combination thereof. Physiological pulse rates may generally fallinto a particular range (e.g., 20-300 BPM for humans), and accordinglysignal conditioning may be used to reduce the presence or effects ofsignal components outside of this particular range. Further, a narrowerpulse range may be expected for a subject, based on previous data forexample, and a signal may be conditioned accordingly. The presence ofnoise may be also be addressed using signal conditioning. For example,ambient radiation (e.g., from artificial lighting, monitors, orsunlight) may impart a noise component in a physiological signal. In afurther example, electronic noise (e.g., system noise) may also impart anoise component in a physiological signal. In a further example, motionor other subject activity may alter a physiological signal, possibleobscuring signal components of interest for extracting rate information.In some embodiments, the Signal Conditioning techniques discussed hereinmay apply to Search Mode, Locked Mode, or any other suitable taskperformed by the processing equipment that may involve a physiologicalsignal.

FIG. 61 is a flow diagram 6100 of illustrative steps for modifying awindow of physiological data (e.g., a segment of an intensity signal)using an envelope, in accordance with some embodiments of the presentdisclosure. In some embodiments, the illustrative steps of flow diagram6100 may aid in conditioning a physiological signal by adjusting abaseline, scaling at least some peaks, or both. In some embodiments, theillustrative steps of flow diagram 6100 may aid in reducing the effectsof low frequency components (e.g., a constant or drifting baseline, peakamplitude changes) during subsequent processing of the window of data.

Step 6102 may include processing equipment buffering a window of data,derived from a physiological signal. In some embodiments, the window mayinclude a particular time interval (e.g., the most recent six seconds ofa processed physiological signal). Step 6102 may include pre-processing(e.g., using pre-processor 320) the output of a physiological sensor,and then storing a window of the processed data in any suitable memoryor buffer (e.g., queue serial module 72 of FIG. 2), for furtherprocessing by the processing equipment. In some embodiments, the windowof data may be recalled from data stored in memory (e.g., RAM 54 of FIG.2 or other suitable memory) for subsequent processing. In someembodiments, the window size (e.g., the number of samples or timeinterval of data to be buffered) of data is selected to capture multipleperiods of oscillatory physiological activity. Panel 6110 shows anillustrative window of data 6112 derived from a physiological signal.

Step 6104 may include the processing equipment generating an envelope(e.g., upper and lower bounding curves) based on the window of data ofstep 6102. The envelope may include an upper trace, which may be anoutline of the peak data values, and a lower trace, which may be anoutline of the valley data values. In some embodiments, the upper andlower traces may be generated using a mathematical formalism such as,for example, a linear or spline fit through the data points. The upperand lower traces may coincide with all, some, or no data points,depending on the enveloping technique used. Any suitable technique maybe used to generate an envelope of the window of data. Panel 6110 showsan illustrative envelope 6114 generated for window of data 6112.

Step 6106 may include the processing equipment modifying thephysiological data of step 6102 based on the envelope of step 6104. Insome embodiments, step 6106 may include generating a new window of data.For example, The midpoint of the difference between the lower and uppertrace at each location may be set as a new origin (e.g., a baseline).The upper and lower traces may then be scaled to respective desiredvalues at each point (e.g., 1 and 0, respectively, or 1 and −1,respectively) and the window of data may be similarly amplitude scaledat each point. In a further example, the lower trace may be subtractedfrom the window of data. The window of data may then be scaled torespective desired values at each point (e.g., to between 2 and 0) basedon the difference between the lower and upper traces. The mean may thenbe subtracted, centering the window of data about zero. Referencing Eq.28 below, either of the two previous examples gives a modified window ofdata M_(−1,1)(x_(i)) for each data point i at data point location x_(i),ranging from −1 to 1, in which f(x_(i)) is the initial window of data,g(x_(i)) is the lower trace, and h(x_(i)) is the upper trace.Referencing Eq. 29 below, either of the two previous examples gives amodified window of data M_(0,1)(x_(i)) for each data point i at datapoint location x_(i), ranging from 0 to 1, in which f(x_(i)) is theinitial window of data, g(x_(i)) is the lower trace, and h(x_(i)) is theupper trace. Any suitable mathematical formula, such as Eqs. 28 or 29,or any other suitable equation, may be used to modify a window of databased on an envelope.

$\begin{matrix}{{M_{{- 1},1}\left( x_{i} \right)} = {\frac{2\left( {{f\left( x_{i} \right)} - {g\left( x_{i} \right)}} \right)}{{h\left( x_{i} \right)} - {g\left( x_{i\;} \right)}} - 1}} & (28) \\{{M_{0,1}\left( x_{i} \right)} = \frac{{f\left( x_{i} \right)} - {g\left( x_{i} \right)}}{{h\left( x_{i} \right)} - {g\left( x_{i\;} \right)}}} & (29)\end{matrix}$

In some embodiments, the processing equipment may down-weight outlierpoints in the buffered window of data. In some embodiments, theprocessing equipment may down-weight one or more points at each end ofthe buffered window of data. It will be understood that the envelope maybe used to modify the physiological data to be within any suitablerange, and that the ranges of 0 to 1, and −1 to 1, are included asillustrative examples.

Panel 6120 shows an illustrative modified window of data 6122, scaled torange from −1 to 1, centered about zero. Note that the lower and uppertraces have been scaled to lie horizontal at −1 and 1, respectively, andwindow of data 6122 has been scaled accordingly. As compared to windowof data 6112, modified window of data 6122 is shown to have a baselineof zero (rather than the trending baseline of window of data 6112), anda more consistent range of peak and valley values. Modified window ofdata 6122 may be used in any of the disclosed Search Techniques, RateCalculation techniques, or any other suitable processes accepting awindow of data derived from a physiological signal as an input.

FIG. 62 is a flow diagram 6200 of illustrative steps for modifyingphysiological data by subtracting a trend, in accordance with someembodiments of the present disclosure. In some embodiments, theillustrative steps of flow diagram 6200 may aid in conditioning aphysiological signal by modifying a baseline. In some embodiments, theillustrative steps of flow diagram 6200 may aid in reducing the effectsof low frequency components (e.g., a constant or drifting baseline)during subsequent processing of the window of data.

Step 6202 may include processing equipment buffering a window of data,derived from a physiological signal. In some embodiments, the window mayinclude a particular time interval (e.g., the most recent six seconds ofa processed physiological signal). Step 6202 may include pre-processing(e.g., using pre-processor 320) the output of a physiological sensor,and then storing a window of the processed data in any suitable memoryor buffer (e.g., queue serial module 72 of FIG. 2), for furtherprocessing by the processing equipment. In some embodiments, the windowof data may be recalled from data stored in memory (e.g., RAM 54 of FIG.2 or other suitable memory) for subsequent processing. In someembodiments, the window size (e.g., the number of samples or timeinterval of data to be buffered) of data is selected to capture multipleperiods of oscillatory physiological activity.

Step 6204 may include the processing equipment generating a signal basedon the window of data of step 6202. The generated signal may represent abaseline or otherwise a trend in the window of data of step 6202. Insome embodiments, the signal generated at step 6204 may include a movingmean, a linear fit (e.g., from a linear regression), a quadratic fit,any other suitable polynomial fit (e.g., using a “least-squares”regression), any other suitable functional fit (e.g., exponential,logarithmic, sinusoidal), any piecewise combination thereof, or anyother combination thereof. Any suitable technique for generating asignal indicative of a trend may be used at step 6204. In someembodiments, each data point within the window of data may be givenequal weighting. In some embodiments the processing equipment maydown-weight outlier points or one or more points at each end of thebuffered window of data.

Step 6206 may include the processing equipment subtracting the generatedsignal of step 6204 from the window of data of step 6202. In someembodiments, step 6206 may include generating a new window of data(e.g., the window data of step 6202 with the signal of step 6204removed), which may be further processed, stored in any suitable memory,or both. Subtraction of the signal of step 6204 from the window of dataof step 6202 may aid in processing the data for rate information byremoving low frequency components. Further illustration of the signalsubtraction of flow diagram 6200 is provided by FIGS. 63-65.

FIG. 63 is a plot 6300 of an illustrative window of data 6302 with themean removed, in accordance with some embodiments of the presentdisclosure. The abscissa of plot 6300 is presented in units proportionalto sample number, while the ordinate is presented in arbitrary units,with zero notated. Window of data 6302 is shown to include an increasingbaseline, even with the mean value of the data removed. Accordingly,subtraction of the mean may provide unsatisfactory results when usedwith data having a changing baseline. In some such circumstances, alinear baseline, or other suitable trending baseline, may be subtractedfrom the window of data rather than a mean value. In some cases, inwhich the baseline of a window of data may be relatively constant, amean subtraction may be preferred to a more complex baseline fit.

FIG. 64 is a plot 6400 of an illustrative window of data 6402 and aquadratic fit 6404, in accordance with some embodiments of the presentdisclosure. The abscissa of plot 6400 is presented in units proportionalto sample number, while the ordinate is presented in arbitrary units. Ascompared to FIG. 63, quadratic fit 6404 follows the trending baseline ofwindow of data 6402 more closely than a mean subtraction would becapable of FIG. 65 a plot 6500 of modified window of data 6502 derivedfrom illustrative window of data 6402 of FIG. 64 with quadratic fit 6404subtracted, in accordance with some embodiments of the presentdisclosure. The abscissa of plot 6500 is presented in units proportionalto sample number, while the ordinate is presented in arbitrary units,with zero notated. Modified window of data 6502 is substantiallycentered about zero, with a relatively constant baseline of zero.

FIG. 66 is a plot 6600 of an illustrative modified window of data 6602derived from an original window of data with the mean subtracted, inaccordance with some embodiments of the present disclosure. The abscissaof plots 6600, 6700, and 6800 of FIGS. 66-68 are presented in unitsproportion to time (or sample number), while the ordinate is presentedin arbitrary units, with zero notated. Modified window of data 6602exhibits significant low frequency activity that is not substantiallyreduced nor eliminated by mean subtraction. Accordingly, modified windowof data 6602 may present challenges for some techniques for extractingrate information. Note that modified window of data 6602 spans seventick marks along the ordinate, in arbitrary units.

FIG. 67 is a plot 6700 of an illustrative modified window of data 6702derived from the same original window of data as FIG. 66 with a linearbaseline subtracted, in accordance with some embodiments of the presentdisclosure. Note that modified window of data 6702 spans almost six tickmarks along the ordinate, in similar units of plot 6600, and accordinglyexhibits relatively less (e.g., smaller amplitude) low frequencyactivity than modified windows of data 6602.

FIG. 68 is a plot 6800 of an illustrative modified window of data 6802derived from the same original windows of data as FIGS. 66 and 67 with aquadratic baseline subtracted, in accordance with some embodiments ofthe present disclosure. Note that modified window of data 6802 spansalmost four tick marks along the ordinate, in similar units of plots6600 and 6700, and accordingly exhibits relatively less (e.g., smalleramplitude) low frequency activity than either of modified windows ofdata 6602 and 6702. In some circumstances, the subtraction of aquadratic fit may provide better results than a mean subtraction orlinear subtraction. In some circumstances, the subtraction of a higherorder polynomial fit, or any other suitable fit, may provide betterresults than a mean subtraction, linear subtraction, or quadraticsubtraction. In some circumstances, a relatively simpler baseline fitmay be preferred to a more complex baseline fit.

Some illustrative effects of signal conditioning will be shown anddiscussed in the context of FIGS. 69-71.

FIG. 69 is a plot 6900 of an illustrative cross-correlation output 6902(using a suitable cross-correlation waveform), calculated using aparticular window of data with the mean removed, in accordance with someembodiments of the present disclosure. The abscissa of plots 6900, 7000,and 7100 of FIGS. 69-71 are presented in units of cross-correlation lag(e.g., in time or samples), while the ordinate is presented in arbitraryunits, with zero notated. Cross-correlation output 6902 may be generatedusing any suitable technique (e.g., using flow diagram 1800 of FIG. 18,or flow diagram 3800 of FIG. 38, or any other technique disclosedherein). The one or more segments of cross-correlation output 6902substantially corresponding to a physiological rate are indicated byregion 6904. Relatively lower frequency components are evident (e.g., inthe area to the left of region 6904), reducing the relative differencein amplitude between segments corresponding to a physiological rate andsegments corresponding to noise.

FIG. 70 is a plot 7000 of an illustrative cross-correlation output 7002(using a suitable cross-correlation waveform), calculated using the sameparticular window of data of FIG. 69 with a linear fit removed, inaccordance with some embodiments of the present disclosure.Cross-correlation output 7002 may be generated using any suitabletechnique (e.g., using flow diagram 1800 of FIG. 18, or flow diagram3800 of FIG. 38, or any other technique disclosed herein). The one ormore segments of cross-correlation output 6902 substantiallycorresponding to a physiological rate are indicated by region 7004.Relatively lower frequency components are evident, forming a secondpeaking structure at the lowest frequencies. However, compared tocross-correlation output 6902, cross-correlation output 7002 exhibitsincreased separation between the physiological peak indicated by 7004and lower frequency noise. The subtraction of a linear fit from a windowof data may, in some circumstances, provide increased peak separationrelative to subtraction of the mean.

FIG. 71 is a plot 7100 of an illustrative cross-correlation output 7102(using a suitable cross-correlation waveform), calculated using the sameparticular window of data of FIGS. 69 and 70 with a quadratic fitremoved, in accordance with some embodiments of the present disclosure.Cross-correlation output 7102 may be generated using any suitabletechnique (e.g., using flow diagram 1800 of FIG. 18, or flow diagram3800 of FIG. 38, or any other technique disclosed herein). The one ormore segments of cross-correlation output 7102 substantiallycorresponding to a physiological rate are indicated by region 7104.Relatively lower frequency components are evident, but of much reducedamplitude relative to cross-correlation outputs 6902 and 7002. The peaksnear highlight 7104 are larger relative to the rest of cross-correlationoutput 7102, as is generally desired, which may allow the peaks to beidentified more accurately, confidently, or both, by at least some ofthe techniques described herein. The subtraction of a quadratic fit froma window of data may, in some circumstances, reduce the amplitude of lowfrequency noise components relative to the subtraction of the mean or alinear fit.

It will be understood that the beneficial effects of signal conditioningare not limited to the examples depicted in FIGS. 69-71. For example,signal conditioning may provide benefits when applied prior toperforming an autocorrelation of a signal and also in the RateCalculation Techniques described below.

In some embodiments, once initialization parameters have been set (e.g.,qualified), the processing equipment may transition to Locked Mode.While operating in Locked Mode, the processing equipment may use thequalified initialization parameters (e.g., filter settings) or otheralgorithm settings from Search Mode to condition, analyze, or both, aphysiological signal to extract physiological rate information. In someembodiments, while operating in Locked Mode, the processing equipmentmay use a previously calculated rate to condition, analyze, or both, aphysiological signal to extract physiological rate information.Performing a Rate Calculation may include further processing of thephysiological signal.

The calculated rate may be qualified, using any suitable QualificationTechnique. For example, any of the Qualification Techniques describedherein may be used to qualify a calculated rate. When qualified, thecalculated rate may be filtered and outputted for display.

FIG. 72 is a flow diagram 7200 of illustrative steps for determining aphysiological rate from threshold crossings based on a physiologicalsignal, in accordance with some embodiments of the present disclosure. Aphysiological signal (and signals derived thereof), whether analog ordigital, may include a number of peaks (e.g., physiological pulsewaves), over which the value of the signal may vary considerably. Insome embodiments, a physiological signal, based on threshold crossings,may be converted into a binary signal, which includes only the valueszero or one, to provide a convenient technique to extract rateinformation.

Step 7202 may include processing equipment receiving a conditionedphysiological signal. The physiological signal may have undergone any ofthe signal conditioning techniques described herein (e.g., filtering,de-trending, modification using an envelope, smoothing), any othersuitable signal conditioning techniques, any suitable signalpre-processing techniques, or any combination thereof. In someembodiments, the conditioned physiological signal may be a conditionedPPG signal, or a signal derived thereof. For example, the conditionedphysiological signal may be a derivative of the IR PPG signal, havingundergone suitable conditioning. In a further example, the conditionedphysiological signal may be an autocorrelation generated from a PPGsignal (e.g., as discussed by suitable steps of flow diagram 500 of FIG.5, flow diagram 900 of FIG. 9, or other suitable techniques), and havingundergone suitable conditioning. In some embodiments, the processingequipment may condition the physiological signal and perform theillustrative steps of flow diagram 7200, and accordingly step 7202 neednot be performed.

Step 7204 may include the processing equipment generating a thresholdsequence (i.e., a collection of threshold values referred tocollectively here as a “threshold”) based on the conditionedphysiological signal of step 7202. The threshold may be used forcomparison with the conditioned physiological signal to extract rateinformation. In some embodiments, the threshold may be a particularfixed value, which may be stored in any suitable memory. In someembodiments, the threshold may be a sequence of one or more adjustablevalues, which may be derived from a mathematical formula (e.g., afunction, a statistical expression), look-up table, or other reference.For example, the adjustable threshold value may be equal to the standarddeviation of the conditioned physiological signal or a portion thereofmultiplied by a coefficient. In some embodiments, the threshold may bydynamic within each calculation of rate. For example, the threshold maybe generated using a Constant False Alarm Rate (CFAR) technique (e.g.,as discussed below with reference to FIGS. 75-80).

Step 7206 may include the processing equipment identifying thresholdcrossings of the conditioned physiological signal of step 7202. Theconditioned physiological signal may include one or more peakscorresponding to a physiological pulse rate, which may cross thethreshold on both an up-stroke and a down-stroke (e.g., providing twothreshold crossings per peak). In some embodiments, a binary signal maybe generated at step 7206 based on the threshold crossings (e.g., FIGS.73-74 provide further illustration of generating a binary signal). Forexample, along the same abscissa as the conditioned physiologicalsignal, the binary signal may be zero for the points where theconditioned physiological signal is less than the threshold and one forpoints where the conditioned physiological signal is greater than orequal to the threshold. Accordingly, the binary signal may include aseries of rectangular pulses among a flat baseline. In some embodiments,the relatively simpler binary signal may be analyzed for rateinformation, rather than the conditioned physiological signal. In someembodiments, the threshold crossings may be identified and analyzeddirectly, and accordingly the binary signal need not be generated. Insome circumstances, the binary signal may provide an illustrativegraphic (e.g., displayed on display 20 of physiological monitoringsystem 10 of FIGS. 1-2) for a user or subject to view.

Step 7208 may include the processing equipment determining rateinformation based on the identified threshold crossings of step 7206. Insome embodiments, a physiological pulse rate may be calculated based onthe threshold crossings. For example, the time interval betweenup-stroke threshold crossings associated with adjacent pulse waves mayprovide a measure of the period of the physiological pulse rate.Similarly, the time interval between the down-stroke crossings, ormidpoint of up-stroke and down-stroke crossings, of adjacent pulse wavesmay provide a measure of the period of the physiological pulse rate. Anysuitable feature(s) of the threshold crossings, or a binary signalgenerated thereof, may be used to calculate a physiological pulse rate.

FIG. 73 is a plot 7300 of an illustrative autocorrelation output 7302,with a Rate Calculation threshold 7304 shown, in accordance with someembodiments of the present disclosure. The abscissa of plot 7300 ispresented in units proportional to autocorrelation lag, while theordinate is presented in arbitrary units. Illustrative autocorrelationoutput 7302 includes six major peaks, which cross threshold 7304.Referencing the leftmost peak of autocorrelation output 7302, theup-stroke crosses threshold 7304 at point 7310 and the down-strokecrosses threshold 7304 at point 7312. While autocorrelation 7302 isrelatively clean and noise-free, there is signal structure (i.e.,detailed shapes) present that does not necessarily provide any benefitduring rate calculation. Generation of a binary signal based onautocorrelation 7302 may provide a simple signal for rate calculation.

FIG. 74 is a plot 7400 of an illustrative binary signal 7402, generatedfrom autocorrelation output 7302 of FIG. 73, which may be used tocalculate a physiological pulse rate, in accordance with someembodiments of the present disclosure. The abscissa of plot 7400 ispresented in units proportional to autocorrelation lag, while theordinate is presented in arbitrary units, with zero and one notated.Binary signal may include one or more rectangular peaks, such as peaks7404 and 7406, which may be used to extract rate information. In part,because of the relatively simple structure of binary signal 7402 ascompared to autocorrelation 7302, calculation of rate information may beaccordingly simplified. In some embodiments, a rate may be calculated bydetermining an interval between adjacent peaks of binary signal 7402,using the interval length as a rate period, and then calculating therate corresponding to the rate period. For example, interval 7410stretches from the midpoint of peak 7404 (i.e., halfway between theup-stroke and down-stroke of a peak in the binary signal) to themidpoint of peak 7406. In a further example, interval 7420 stretchesfrom the down-stroke of peak 7404 to the down-stroke of peak 7406. In afurther example, interval 7430 stretches from the up-stroke of peak 7404to the up-stroke of peak 7406. Any of intervals 7410, 7420, 7430, anyother suitable intervals, or any combination thereof may be used tocalculate rate information. In some embodiments, the two most recentpeaks may be used to calculate rate information. In some embodiments,more than one pair of peaks may be used to calculate the rateinformation. For example, an average interval or median interval may becalculated based on multiple pairs of peaks. In a further example, aweighted average (e.g., weighted to down-weight outliers, weighted toup-weight more recent data) of interval length may be calculated. In afurther example, a histogram may be generated of interval values, andthe interval (or range thereof) occurring most often may be selected asthe pulse period.

FIG. 75 is a flow diagram 7500 of illustrative steps for determining aRate Calculation threshold based on a CFAR setting, in accordance withsome embodiments of the present disclosure. The CFAR technique may use aCFAR window (which may be referred to as a “threshold window”), whichmay include the sample under test, guard samples, and base samples. Thethreshold window may include a center portion (e.g., the sample undertest and guard samples) that is not used to generate the threshold valueat each sample under test. Accordingly, the threshold value for thesample under test is based on the surrounding samples, and not, forexample, on the sample under test and guard samples. The CFAR techniquemay be especially useful in identifying peaks in otherwise noisysignals.

Step 7502 may include the processing equipment receiving aninitialization parameter, previously calculated rate, any other suitablequalification information, or any combination thereof. In someembodiments, step 7502 may include recalling the stored initializationparameter, previously calculated rate, or both, from suitable memory. Insome embodiments, a single processor, module, or system may calculate,store, or both, initialization parameters and the previously calculatedrate, and perform steps 7504-7508, and accordingly, step 7502 need notbe performed. The rate associated with the received initializationparameters, calculated rate, or both will be referred to as a “CFARSetting,” which may be included as a part of algorithm settings.

Step 7504 may include the processing equipment determining a CFAR guardsize based on the CFAR setting of step 7502. A guard is a set of one ormore samples on either, or both, sides of the sample under test that arenot included in the threshold calculation. The size of the guard mayrefer to the number of samples, the time interval, or any other sizemetric indicative of a guard. In some embodiments, the guard size may bebased on the period of a previously calculated rate. For example, theguard size may be equal to one fifth of the period of the previouslycalculated rate. In some embodiments, the guard size may bepredetermined.

Step 7506 may include the processing equipment determining a CFAR widthof base samples based on the CFAR setting of step 7502. The CFAR widthis the set of samples on either, or both, sides of the sample undertest, outside of the guard, which are used in the threshold calculation(referred to herein as the “base samples”). The CFAR width may refer tothe number of samples, the time interval, or any other size metricindicative of a width. In some embodiments, the CFAR width may be basedon the period of a previously calculated rate (e.g., may be a linear ornon-linear function of period P). For example, the CFAR width may beequal to two thirds of the period of the previously calculated rate,minus the guard size (i.e., CFAR width =(⅔)P−guard size). In someembodiments, the CFAR guard size and CFAR width may decrease as period Pdecreases. The sizing of the CFAR components (e.g., the guard size andnumber of base samples) will also be referred to as a “CFAR Setting.”

Step 7508 may include the processing equipment determining a thresholdvalue based on the values of the base samples within the CFAR width foreach sample under test. Step 7508 may include determining a thresholdvalue at each sample under test, to generate a threshold sequence. Thethreshold sequence may be generated for comparison with a conditionedphysiological signal, or signal derived thereof (e.g., anautocorrelation), to determine rate information. In some embodiments,the mean and standard deviation may be calculated for the base samples.For example, the local threshold value T(x_(k)) at point x_(k) may begiven by Eq. 30 below:

T(x _(k))=μ_(k) +Kσ _(k)  (30)

in which μ_(k) is the mean of the base samples, K is a coefficient, andσ_(k) is the standard deviation of the base samples. The coefficient Kmay have any suitable constant or variable value such as, for example, apredefined constant value, a value depending on the initializationparameters, a value varying with CFAR settings, or other suitable value.For example, K may depend linearly or non-linearly on the rateassociated with the initialization parameters or a previously calculatedrate. The coefficient K will also be referred to as a “CFAR Setting.”

In some embodiments, the size and properties of a CFAR window may dependon characteristics of the underlying signal. For example, the number ofguard samples, the number of base samples, the number of guard or basesamples to either side of the sample under test (i.e., the symmetry ofthe CFAR window), the coefficient K, any other suitable CFAR windowproperties, or any combination thereof, may be adjusted based on theunderlying signal. Any suitable CFAR property may be adjusted based on,for example, statistical properties of the underlying signal (e.g.,mean, standard deviation), a trend of the underlying signal, a shape ofthe underlying signal, an initialization parameter, a previouslycalculated rate, any other suitable signal property, or any combinationthereof. For example, as a physiological rate increases, the number ofguard samples and the number of base samples may decrease for a fixedsampling rate.

FIG. 76 shows an illustrative CFAR window 7600, including the sampleunder test 7602, guard samples 7604, and base samples 7606, inaccordance with some embodiments of the present disclosure. CFAR window7600, or portions thereof, may be used to generate a threshold value(e.g., using the illustrative steps of flow diagram 7500) at thelocation of the sample under test. Included in CFAR window 7600 may besample under test 7602, immediately surrounded by guard samples 7604.Base samples 7606 lie outside of guard samples 7604 relative to sampleunder test 7602. In some embodiments, base samples 7606 are used todetermine a threshold value for sample under test 7602. For example, Eq.30 may be applied to base samples 7606 of CFAR window 7600 to generate athreshold value. A window similar to CFAR window 7600 may be generatedat each point of a conditioned physiological signal, or signal derivedthereof (e.g., an autocorrelation output), creating a threshold curve. Athreshold curve may be used for comparison with, for example, theautocorrelation output from which the threshold was derived.

FIG. 77 is a plot 7700 of an illustrative autocorrelation output 7702,with three illustrative CFAR windows 7710, 7720, and 7730 shown, inaccordance with some embodiments of the present disclosure. The abscissaof plot 7700 is presented in units of autocorrelation lag, while theordinate is presented in arbitrary units. The samples under test of CFARwindows 7710, 7720, and 7730 are highlighted by circles, correspondingto an “X” in the center of each window. The base samples of each CFARwindow are shown with cross-hatching, while the guard samples on eitherside of the samples under test are shown with no hatching. The basesamples of CFAR windows 7710 and 7730 are relatively larger vales thanthe respective samples under test of CFAR windows 7710 and 7730.Accordingly, in some embodiments, the threshold value calculated forCFAR windows 7710 and 7730 may be relatively large compared to therespective samples under test. The base samples of CFAR window 7720 arerelatively smaller values than the sample under test of CFAR window7720. Accordingly, in some embodiments, the threshold value calculatedfor CFAR window 7720 may be relatively small compared to the sampleunder test. In some embodiments, the number of samples used to determinestatistical metrics may determine the minimum detection spacing. In someembodiments, guard samples may be used to prevent inclusion of a sampleunder test in a statistical calculation about the sample under test.

FIG. 78 is a plot 7700 of the illustrative autocorrelation output 7702of FIG. 77, with a threshold 7802 generated based in part on the CFARwindows of FIG. 77, in accordance with some embodiments of the presentdisclosure. The abscissa of plot 7800 is presented in units ofautocorrelation lag, while the ordinate is presented in arbitrary units.As discussed in the context of FIG. 77, threshold values calculated forsamples under test near a peak may be relatively smaller than thresholdvalues calculated for samples under test near a trough. Threshold 7802exhibits a relatively low value near the peak of autocorrelation output7702, and relatively higher values away from the peak. Intersections7810 and 7820 between autocorrelation output 7702 and threshold 7802 maybe used to, for example, generate a binary pulse of a binary signal,which may be used to determine a physiological pulse rate.

FIG. 79 is a plot 7900 of an illustrative autocorrelation output 7902and a Rate Calculation threshold 7904, in accordance with someembodiments of the present disclosure. The abscissa of plot 7900 ispresented in units of autocorrelation lag, while the ordinate ispresented in arbitrary units, with zero notated. Threshold 7904 isgenerated using a series of CFAR windows (e.g., as described by flowdiagram 7500 of FIG. 75). The CFAR windows included a guard of foursamples (on each side) and a width of twelve samples (on each side).Autocorrelation output 7902 exhibits a set of smaller peaks, indicativeof physiological pulses that include dicrotic notches. Accordingly, thesmaller peaks do not correspond to a physiological rate, but rather thelarger peaks correspond to a physiological rate. The troughs ofthreshold 7904 are relatively higher than the zeniths of thecorresponding smaller peaks. A binary signal generated fromautocorrelation output 7902 and threshold 7904 (e.g., as shown in FIG.80) may avoid including the smaller peaks that are indicative ofdicrotic notches. Note that in FIG. 79, autocorrelation output 7902 isassociated with a pulse rate of 85 BPM.

FIG. 80 is a plot 8000 of an illustrative binary signal 8002 generatedbased on the intersections of autocorrelation output 7902 and RateCalculation threshold 7904 of FIG. 79, in accordance with someembodiments of the present disclosure. The abscissa of plot 8000 ispresented in units of autocorrelation lag, while the ordinate ispresented in arbitrary units, with zero and one notated. The smallerpeaks of autocorrelation output 7902, indicating the presence ofdicrotic notches, are not included as binary pulses in binary signal8002. Accordingly, the CFAR windows used to generate threshold 7904 arecorrectly sized. In some embodiments, binary signal 8002 may be furtheranalyzed to calculate a pulse rate.

FIG. 81 is a flow diagram 8100 of illustrative steps for selecting anautocorrelation template size to perform an autocorrelation, inaccordance with some embodiments of the present disclosure. The size ofan autocorrelation template may be based on initialization parameters, acalculated rate or other information. For example, the period Passociated with initialization parameters and/or a calculated rate maybe used to select an autocorrelation template size.

Step 8102 may include processing equipment receiving initializationparameters, a previously calculated rate, any other suitable rateinformation, or any combination thereof. In some embodiments, step 8102may include recalling the stored initialization parameter, previouslycalculated rate, or both, from suitable memory. In some embodiments, asingle processor, module, or system may calculate, store, or both,initialization parameters and the previously calculated rate, andperform steps 8104-8106, and accordingly, step 8102 need not beperformed.

Step 8104 may include the processing equipment selecting anautocorrelation template size based on the received initializationparameters and/or previously calculated rate of step 8102. In someembodiments, the processing equipment may select an autocorrelationtemplate size that is equal to the period associated with the receivedinitialization parameters and/or previously calculated rate. In someembodiments, the processing equipment may select an autocorrelationtemplate size that is greater than or less than the period associatedwith the received initialization parameters and/or previously calculatedrate. For example, the processing equipment may input the receivedinitialization parameters and/or previously calculated rate of step 8102into a mathematical expression and/or look-up table, and determine anautocorrelation template size.

Step 8106 may include the processing equipment performing anautocorrelation on a window of data, using the autocorrelation templatesize selected at step 8104. In some embodiments, the autocorrelation ofstep 8106 may include correlating a first portion of the window of data(i.e., the template of selected size) with a second portion of thewindow of data (e.g., the remaining window of data). The first andsecond portions may be exclusive of one another, may share one or moresamples, or may be selected by any other suitable partition of thewindow of data. For example, a six second window of data may be bufferedfrom a physiological signal. The processing equipment may determine thatthe previously calculated rate is 60 BPM, and may determine that theperiod associated with the current rate is likely to be approximately 1second. The processing equipment may select an autocorrelation templatesize of 1 second to perform the autocorrelation of step 8106, or use alook-up table (e.g., stored in memory of system 10) to select anautocorrelation template size to perform the autocorrelation of step8106. In a further example, a six second window of data may be bufferedfrom a physiological signal. The processing equipment may determine thatthe previously calculated rate is 120 BPM, and may determine that theperiod associated with the current rate is likely to be approximately0.5 seconds. The processing equipment may select an autocorrelationtemplate size of 0.5 second (e.g., about 1 period) to perform theautocorrelation of step 8106. In some embodiments, the resultingautocorrelation output of step 8106 may be further analyzed using any ofthe techniques disclosed herein.

FIG. 82 is a flow diagram 8200 of illustrative steps for qualifying anautocorrelation template, in accordance with some embodiments of thepresent disclosure. Qualification of a template may be used to selectand store a template that provides desired performance, which may aid insystem 300 determining initialization parameters and/or calculating arate.

Step 8202 may include processing equipment receiving initializationparameters, a previously calculated rate, or both. In some embodiments,the initialization parameters, a previously calculated rate, or both,may be generated at an earlier time, and stored in suitable memory(e.g., RAM 54 of physiological monitoring system 10 of FIGS. 1-2).Accordingly, in some embodiments, step 8202 may include recalling theinitialization parameters, a previously calculated rate, or both, frommemory. In some embodiments, a single processor, module, or system maydetermine, store or otherwise process the initialization parameters andpreviously calculated rate, as well as perform steps 8204-8218, andaccordingly, step 8202 need not be performed.

Step 8204 may include the processing equipment determining whether atemplate has been stored. In some embodiments, one or more templates maybe stored in memory (e.g., ROM 52, RAM 54 of system 10 or other suitablememory). In some embodiments, the processing equipment may access one ormore local memory devices, access one or more remote memory devices,perform a search of one or more stored templates, perform any othersuitable operation to determine whether a template has been stored, orany combination thereof. At step 8204, the processing equipment maydetermine that a template has or has not been stored, and accordinglymay proceed to step 8206 or step 8208, respectively. In someembodiments, the stored template may be a window of data derived from aphysiological signal of the subject. For example, one or more templatesderived from a window of data having relatively low-noise may be storedfor future use (e.g., at step 8218). In some embodiments, the storedtemplate may be derived from a standard template shape and/or amathematical function. In some embodiments, step 8204 may includeselecting the stored template from memory.

Step 8206 may include the processing equipment scaling the storedtemplate of step 8204 based on initialization parameters and/or apreviously calculated rate. The template may be scaled to exhibit aperiod equal to the period P associated with the initializationparameters and/or previously calculated rate. For example, if the periodP associated with the initialization parameters is 1 second (e.g., for a60 BPM rate), the template may be scaled to exhibit a period of 1second.

In some embodiments, step 8206 may include the processing equipmentselecting more than one stored autocorrelation templates based oninitialization parameters and/or a previously calculated rate. In someembodiments, the processing equipment may average the templates togenerate a composite template to be used in the remaining steps of flowdiagram 8200. In some embodiments, the processing equipment may processthe templates separately in the remaining steps of flow diagram 8200.

Step 8208 may include the processing equipment selecting anautocorrelation template size based on initialization parameters and/ora previously calculated rate. In circumstances where no suitabletemplate has been stored, the processing equipment may select anautocorrelation template from a buffered window of data. For example,referencing a six second buffered window of data, the most recent onesecond of data may be selected as a template to be correlated with theentire six seconds of data. In some embodiments, the processingequipment may select the autocorrelation template size based on a periodP associated with initialization parameters and/or a previouslycalculated rate. For example, if the period P associated with theinitialization parameters is 1 second (e.g., for a 60 BPM rate), atemplate of 1 second may be selected.

Step 8210 may include the processing equipment performing anautocorrelation on a window of data, using an autocorrelation templateof either step 8206 or 8208. The autocorrelation template and the windowof data may be exclusive of one another, may share one or more samples,or may be selected by any other suitable partition of the physiologicalsignal. The autocorrelation output of step 8210 may include one or morepeaks, which may indicate correlation of the template with the window ofdata. Step 8210 may also include the processing equipment calculating arate based on the autocorrelation. The processing equipment mayimplement any of the Search Mode and/or Locked Mode techniques disclosedherein to calculate the rate. In some embodiments, the processingequipment may perform more than one correlation operation at step 8210.For example, a correlation operation may be performed on multipletemplates against the physiological signal. The template that has thehighest correlation can be selected for use as the template in theautocorrelation. The stored templates may include templates withdicrotic notches of different sizes, amounts of skew, symmetry, anyother suitable properties, or any combination thereof. In a furtherexample, the processing equipment may perform an autocorrelation andCFAR analysis for each of multiple selected templates. The processingequipment may select the template associated with the highest confidencevalue. A confidence value may include, for example, the amount by whichthe autocorrelation exceeds a threshold (e.g., a CFAR threshold).

Step 8212 may include the processing equipment identifying a newreference waveform (e.g., a new potential template) from a raw orconditioned physiological signal (e.g., a photoplethysmograph signal).In some embodiments, the new potential template may be selected byanalyzing the physiological signal. For example, the processingequipment may select a portion of the physiological signal between twopeaks (e.g., two adjacent maxima), between two valleys (e.g., twoadjacent minima), between two zero crossings, or other suitable portionof the physiological signal, or any combination thereof, to be atemplate. Identifying the new potential template may include locating amaximum or minimum signal value, a maximum or minimum value in aderivative of a signal, a zero crossing of a signal, a zero crossing ina derivative of a signal, any other suitable reference points, or anycombination thereof. In some embodiments, the processing equipment mayidentify a new potential template based on the calculated rate of step8210. For example, the processing equipment may determine a period Passociated with the calculated rate of step 8210, and select a templatehaving a length of P (or fraction or multiple thereof) from thephysiological signal.

Step 8214 may include the processing equipment analyzing the newpotential template of step 8212. In some embodiments, the analysis ofstep 8214 may include analyzing the shape of the template (e.g., a peakvalue, a peak to width ratio, a full width at half maximum value), theskewness of the template, the relative amplitude of the template, thecorrespondence of the template to one or more other templates, any otherproperty of the template, or any combination thereof. In someembodiments, the analysis of step 8214 may include determining a noisemetric and/or a confidence metric based on the physiological signalassociated with the new potential template.

Step 8216 may include the processing equipment determining whether thenew potential template of step 8212 is qualified based on the analysisof step 8214. In some embodiments, step 8216 may include comparing ametric determined at step 8214 with a threshold value to determinewhether to qualify the new potential template. For example, a noisemetric such as signal to noise ratio calculated at step 8214 may becompared to a noise threshold and if the noise metric is greater thanthe noise threshold, the template may be determined to be unqualified.Accordingly, under relatively low noise conditions, a new template maybe qualified each time steps 8210-8216 are performed. As one or morenoise metrics increase beyond some threshold value, the processingequipment may cease updating the template and continue to use thetemplate qualified under the relatively low-noise conditions. In someembodiments, if the new potential template is disqualified at step 8216,the template may be discarded. For example, the new potential templatemay be erased from memory storage, or otherwise made unavailable forfurther consideration if disqualified at step 8216.

Step 8218 may include the processing equipment storing the qualifiedtemplate of step 8216 in suitable memory. The qualified template may bestored, for example, in RAM 54 of system 10. In some embodiments, aqualified template may be stored in a database of templates. In someembodiments, the qualified template may be stored and indexed by thecalculated rate value for subsequent use. Accordingly, a stored templatemay be recalled at step 8204 in circumstances where, for example, theindex matches the initialization parameters and/or calculated rate ofstep 8202. In some embodiments, a stored template may have been derivedfrom a subject's physiological signals. In some embodiments, a storedtemplate may have been derived from a standard (e.g., typical)physiological signal shape, a mathematical function, or derived from anyother suitable source, or any combination thereof.

In some embodiments, the processing equipment may combine metrics,qualifications/disqualifications, any other suitable information, or anycombination thereof in a neural network to determine which Technique maybe desired under some circumstances. In some embodiments, as system 300processes data over time, the processing equipment may use a neuralnetwork, or any other suitable classifier, to adapt the Techniques andparameters thereof used by the processing equipment to determinephysiological information of a subject. For example, as templates arequalified and/or disqualified at step 8216, the processing equipment mayadjust or otherwise update thresholds, criterion, or analysis techniquesto select initialization parameters or determine rates having higherprobabilities of being qualified.

FIG. 83 is a flow diagram 8300 of illustrative steps for classifying aphysiological signal to be used in Search Mode and/or Locked Mode, inaccordance with some embodiments of the present disclosure.Classification of a physiological signal may aid in determininginitialization parameters and/or calculating a rate, by furtherdirecting the analysis of the physiological signal. For example, filtersettings, expected pulse rate range, subject classification (e.g.,neonate or adult), the presence of a dicrotic notch, pulse shape (e.g.,skew), and/or any other suitable classification may be used to determinethe type of analysis to perform on a physiological signal.

Step 8302 may include processing equipment receiving at least onephysiological signal from a physiological sensor, memory, any othersuitable source, or any combination thereof. For example, referring tosystem 300 of FIG. 3, the processing equipment may receive aphysiological signal from input signal generator 310. Sensor 318 ofinput signal generator 310 may be coupled to a subject, and may detectphysiological activity such as, for example, RED and/or IR lightattenuation by tissue, using a photodetector. In some embodiments,physiological signals generated by input signal generator 310 may bestored in memory (e.g., memory of system 10 of FIGS. 1-2) after beingpre-processed by pre-processor 320. In such cases, step 8302 may includerecalling the signals from the memory for further processing.

The physiological signal of step 8302 may include a PPG signal, whichmay include a sequence of pulse waves and may exhibit motion artifacts,noise from ambient light, electronic noise, system noise, any othersuitable signal component, or any combination thereof. Step 8302 mayinclude receiving a particular time interval or corresponding number ofsamples of the physiological signal. In some embodiments, step 8302 mayinclude receiving a digitized, sampled, and pre-processed physiologicalsignal.

Step 8304 may include the processing equipment classifying the at leastone received physiological signal of step 8302. The processing equipmentmay perform the classification using any suitable set of classes, whichmay be based on signal quality, signal properties, subject properties,any other suitable types of classes having any suitable number ofclasses, or combination thereof. Illustrative classifications mayinclude, for example, subject age (e.g., neonate/child/adult), high/lowmotion artifact (e.g., motion of a subjects limbs), dicrotic notch/nodicrotic notch, high/low pulse skewness, likely pulse rate range, signalnoisiness, any other suitable classification having any suitable numberof classes, or any combination thereof. For example, the skewness S of nsamples (e.g., corresponding to one or more pulse waves) may bedetermined using Eq. 31a:

$\begin{matrix}{S = \frac{\frac{1}{n}\left( {\sum\limits_{i = 1}^{n}\left( {x_{i} - \overset{\_}{\mu}} \right)^{3}} \right)}{\left( {\frac{1}{n\;}\left( {\sum\limits_{i = 1}^{n}\left( {x_{i} - \overset{\_}{\mu}} \right)^{2}} \right)} \right)^{3/2}}} & \left( {31a} \right)\end{matrix}$

where μ is the sample mean, and x_(i) is sample i. In some embodiments,the processing equipment may use the classification to modify how Searchand/or Locked Modes operate. For example, if a PPG signal is classifiedas a neonate PPG signal, the signal may be high passed or band-passed toreduce or eliminate frequencies less than about 85 BPM because neonatestypically have rate higher than 100 BPM. In a further example,qualification tests to be performed may be changed, or the thresholdsmay be changed, based on the classification. For example, if a PPGsignal is classified as having a dicrotic notch, additional orrelatively more stringent tests may be applied to make sure the dicroticnotch is not causing the rate to be calculated as double the true rate.If double the true rate is detected, then the calculated rate may behalved and provided as an output. In some embodiments step 8304 mayinclude receiving user input to user inputs 56 of system 10. Forexample, a user may indicate that the received physiological signal isfrom a neonate, has a dicrotic notch, and/or likely includes a pulserate in a particular range. In some embodiments, in which the processingequipment is unable to classify a physiological signal and/or no userindication is received, the processing equipment need not classify thephysiological signal and may proceed using any of the techniquesdisclosed herein.

Step 8306 may include the processing equipment determining whetherinitialization parameters have been set. In some embodiments,initialization parameters may include one or more algorithm settingssuch as, for example, indexes for inputting into a look-up table, filtersettings, and/or templates. In some embodiments, initializationparameters may include one or more settings of a band pass filter suchas, for example, a high and low frequency cutoff value (e.g., afrequency range), a representative frequency value, a set of one or morecoefficients, any other suitable parameters, or any combination thereof.Physiological monitoring system 10 may use initialization parameters toimprove data processing (e.g., reduce computational requirements,improve accuracy, reduce the effects of noise) to extract physiologicalinformation in the presence of noise. This may be accomplished byeffectively limiting the bandwidth of data to be analyzed, performing arough calculation to estimate a physiological pulse, or otherwisemathematically manipulating physiological data. In some embodiments,following a change in classification, the processing equipment maydetermine that initialization parameters are to be reset. In someembodiments, in which more than two classes exist, the processingequipment may determine whether initialization parameters are to bereset based on the relative change in classification. For example, aphysiological signal may be classified by noise level, and theprocessing equipment may determine whether initialization parameters areset depending on the change in noise level. In some embodiments, step8306 may be independent of the classification of step 8304.

Depending upon the determination of step 8306, the processing equipmentmay enter Search Mode at step 8308 or Locked Mode at step 8310. Step8308 may include system 300 performing any suitable Search Modeoperation such as, for example, performing signal conditioning,determining one or more initialization parameters, qualifying one ormore initialization parameters, determining whether initializationparameters are qualified, any other suitable operations, or anycombination thereof. Step 8310 may include system 300 performing anysuitable Locked Mode operation such as, for example, performing signalconditioning, determining one or more initialization parameters,calculating a physiological rate, qualifying a calculated physiologicalrate, determining whether a physiological rate is qualified, filteringand/or outputting a calculated rate, any other suitable operations, orany combination thereof.

In an illustrative example, a physiological signal may be classified ashaving a dicrotic notch. The processing equipment may, accordingly,determine that a calculated value (e.g., a calculated rate and/orinitialization parameters) corresponds to a harmonic of thephysiological rate. In some such circumstances, the processing equipmentmay modify the calculated value to obtain the physiological rate whenthe classification of the physiological signal is a dicrotic notchclassification. For example, if an intensity signal is classified ashaving a dicrotic notch, the processing equipment may determine that onehalf of the calculated value corresponds to the physiological rate.

FIG. 84 is a flow diagram 8400 of illustrative steps for classifying aphysiological signal, in accordance with some embodiments of the presentdisclosure. The steps of illustrative flow diagram 8400 may provide anexemplary embodiment of step 8304 of flow diagram 8300.

Step 8402 may include processing equipment receiving at least onephysiological signal from a physiological sensor, memory, any othersuitable source, or any combination thereof. For example, referring tosystem 300 of FIG. 3, the processing equipment may receive aphysiological signal from input signal generator 310. Sensor 318 ofinput signal generator 310 may be coupled to a subject, and may detectphysiological activity such as, for example, RED and/or IR lightattenuation by tissue, using a photodetector. In some embodiments,physiological signals generated by input signal generator 310 may bestored in memory (e.g., RAM 54 of FIG. 2 or other suitable memory) afterbeing pre-processed by pre-processor 320. In such cases, step 8402 mayinclude recalling the signals from the memory for further processing.

Step 8404 may include the processing equipment applying a filter such asa low-pass filter (LPF) or high-pass filter (HPF) to the receivedphysiological signal of step 8402. In some embodiments, applying thefilter may include separating the physiological signal into a lowfrequency signal component and a high frequency signal component (i.e.,relatively higher frequency activity), as shown in FIG. 84. Theprocessing equipment may apply the filter having any suitable spectralcharacter (e.g., the LPF may be a Bessel filter, Chebyshev filter,elliptic filter, Butterworth filter, or other suitable low-pass filter,having any suitable spectral cutoff). For example, the processingequipment may apply a LPF having a 75 BPM cut-off at step 8404 (e.g.,which attenuates frequencies greater than approximately 75 BPM). In afurther example, the processing equipment may apply a HPF having a 75BPM cut-off at step 8404 (e.g., which attenuates frequencies less thanapproximately 75 BPM). The 75 BPM cut-off is exemplary and any othersuitable BPM cutoff can be used to separate the intensity signal intohigh and low frequency components.

Step 8406 may include the processing equipment determining a noisemetric based on the low frequency component outputted at step 8404. Insome embodiments, the processing equipment may apply a LPF (separatefrom the filter of step 8404) to the LF signal, and then compare theinput and output signals to the second LPF. For example, step 8404 mayinclude applying a LPF with a cutoff of 75 BPM, and step 8406 mayinclude the processing equipment applying a second LPF with a cutoff of6 BPM. The processing equipment may determine the difference between theinput and output signals of the 6 BPM LPF, and then determine a rootmean square value of the difference as the noise metric.

Step 8408 may include the processing equipment calculating a kurtosis(e.g., the fourth standardized moment of a signal or corrected valuethereof) of the LF signal output at step 8404. In some embodiments, forexample, the processing equipment may calculate the kurtosis K for asignal of n samples using Eq. 31:

$\begin{matrix}{K = {\frac{\frac{1}{n}\left( {\sum\limits_{i = 1}^{n}\left( {x_{i} - \overset{\_}{\mu}} \right)^{4}} \right)}{\left( {\frac{1}{n\;}\left( {\sum\limits_{i = 1}^{n}\left( {x_{i} - \overset{\_}{\mu}} \right)^{2}} \right)} \right)^{2}} - 3}} & \left( {31b} \right)\end{matrix}$

where μ is the sample mean, and x_(i) is sample i. The kurtosis of asignal may provide an indication of a relative measure of sharpness of adistribution (e.g., high kurtosis indicates a relatively sharp peak andrelatively large tails).

Step 8410 may include the processing equipment calculating a standarddeviation of the LF signal output at step 8404. In some embodiments, theprocessing equipment may calculate the standard deviation a for a signalof n samples using Eq. 32:

$\begin{matrix}{\sigma = \sqrt{\frac{1}{n}\left( {\sum\limits_{i = 1}^{n}\left( {x_{i} - \overset{\_}{\mu}} \right)^{2}} \right)}} & (32)\end{matrix}$

where μ is the sample mean, and x_(i) is sample i. The standarddeviation of a signal may provide an indication of sample variabilityabout a mean value.

Step 8412 may include the processing equipment calculating a kurtosis ofthe HF output at step 8404. In some embodiments, the processingequipment may calculate the kurtosis K for a signal of n samples usingEq. 31, in which the samples and mean are based on the HF signal. Step8414 may include the processing equipment calculating a standarddeviation of the HF output at step 8404. In some embodiments, theprocessing equipment may calculate the standard deviation σ for a signalof n samples using Eq. 32, in which the samples and mean are based onthe HF signal.

It will be understood that steps 8406, 8408, 8410, 8412, and 8414 may beperformed in any suitable order between steps 8404 and 8416.

Step 8416 may include the processing equipment performing comparisonanalysis between the LF signal and the HF signal output at step 8404. Insome embodiments, step 8416 may include the processing equipmentcomparing one or more signal metrics from the LF signal and HF signaloutput at step 8404. In some embodiments, at step 8416, the processingequipment may compare the kurtosis (e.g., from steps 8408 and 8412),standard deviation (e.g., from steps 8410 and 8414), any other suitablesignal metric, or any combination thereof. For example, the processingequipment may determine which of the LF signal and the HF signal has alarger kurtosis, standard deviation, and/or other signal metric. In someembodiments, step 8416 may include the processing equipment performingindependent component analysis (ICA) using the LF signal, the HF signal,the at least one physiological signal of step 8402, or any combinationthereof. For example, ICA analysis may be used to separate the componentof a physiological signal associated with a physiological rate from anoise components or other undesired component of the signal.

Step 8418 may include the processing equipment selecting either the LFsignal or the filter residual signal output at step 8404. In someembodiments, the processing equipment selecting between the LF and HFsignals outputted at step 8404. In some embodiments, the processingequipment may select one signal component and disregard the other,non-selected signal component. For example, the processing equipment maydetermine at step 8416 that the LF signal has a higher kurtosis and/orstandard deviation than the HF signal, and accordingly may select the LFsignal for conditioning at step 8420.

Step 8420 may include the processing equipment performing signalconditioning on the selected signal component of step 8418. In someembodiments, step 8420 may include de-trending the selected signalcomponent. For example, the processing equipment may subtract aquadratic fit (e.g., or any other suitable de-trending such as thosediscussed in flow diagrams 6100 or 6200) from the selected signalcomponent of step 8418. In some embodiments, the processing equipmentmay proceed to enter Search Mode or Locked Mode, and perform furtherprocessing using the conditioned, selected signal of step 8418.

FIG. 85 is a flow diagram 8500 of illustrative steps for providing aFast Start, in accordance with some embodiments of the presentdisclosure. Fast Start may be used in circumstances where a reduced-sizewindow of data may be available and/or desired. In some embodiments,Fast Start allows system 300 or system 10 to start processing aphysiological signal before an entire buffer (e.g., 6 or 7 seconds ofdata) is obtained. Fast Start may be especially useful during start-up,and/or start of data collection, of system 10 or system 300. An entirebuffer of data (e.g., 6 seconds in this example, although an entirebuffer may be any suitable length), for example, is typically onlyneeded to accurately compute rates down to 20 BPM. Since most rates are60 BPM or higher, system 300 or system 10 can begin processing sooner.

Step 8502 may include processing equipment determining Fast Startparameter(s). Fast Start parameters may include buffer sizes of aphysiological signal, autocorrelation templates sizes, an increment ofincrease in buffer size and/or template size, a time and/or availablebuffer size to end Fast Start, autocorrelation analysis parameters,signal conditioning parameters, any other suitable parameters, or anycombination thereof. For example, step 8502 may include determining astarting buffer and template size (e.g., a two second buffer and a halfsecond template). In a further example, step 8502 may includedetermining how to increment the buffer and template size as more datais available and/or desired (e.g., increase the buffer size by onesecond for each calculation with the template being a fixed proportionof the buffer). In a further example, step 8502 may include determiningthat when a six second buffer of data is available, system 300 maytransition out of Fast Start mode and begin normal operation. In afurther example, step 8502 may include determining parameters used inthe autocorrelation analysis of step 8510. In a further example, step8502 may include determining signal conditioning parameters such ascurve fit subtraction parameters. In some embodiments, step 8502 mayinclude the processing equipment determining whether to operate in FastStart mode.

Step 8504 may include the processing equipment buffering a window ofdata, derived from a physiological signal. In some embodiments, thewindow may include a particular time interval, as included in the FastStart parameters of step 8502. Step 8504 may include pre-processing(e.g., using pre-processor 320) the output of a physiological sensor,and then storing a window of the processed data in any suitable memoryor buffer (e.g., queue serial module 72 of FIG. 2), for furtherprocessing by the processing equipment. In some embodiments, the windowof data may be recalled from data stored in memory (e.g., RAM 54 of FIG.2 or other suitable memory) for subsequent processing. In someembodiments, the window size (e.g., the number of samples or timeinterval of data to be buffered) of data may be selected based on FastStart parameters of step 8502. The window of data buffered during a FastStart may be relatively smaller than the preferred buffer size duringnormal operation.

Step 8506 may include the processing equipment performing signalconditioning on the window of data of step 8504. Signal conditioning mayinclude removing DC components, low frequency components, or both, fromthe window of data. In some embodiments, a varying baseline may beremoved from the window of data (i.e., de-trending) to constrain thedata average to zero. In some embodiments, the signal conditioning ofstep 8506 may be based on Fast Start parameters of step 8502.

Step 8508 may include the processing equipment performing anautocorrelation on the conditioned window of data of step 8506. In someembodiments, the autocorrelation of step 8508 may include correlating afirst portion of the window of data (i.e., the template) with a secondportion of the window of data. The first and second portions may beexclusive of one another, may share one or more samples, or may beselected by any other suitable partition of the window of data. In someembodiments, the processing equipment may pad the buffered window ofdata with zeros, or other suitable padding values such as white noise(e.g., to increase the buffer size in terms of time interval/samplenumber). For example, if the processing equipment is configured toperform an autocorrelation using six seconds of data (e.g., a window ofdata under non-Fast Start conditions), but only two seconds is availablefrom the buffer during Fast Start, the processing equipment may pad thebuffered data with four seconds of zeros to create the six secondwindow. In a further example, if the processing equipment is configuredto perform an autocorrelation using six seconds of data (e.g., a windowof data under non-Fast Start conditions), but only two seconds isavailable from the buffer during Fast Start, the processing equipmentmay pad the buffered data with four seconds of suitably scaled randomnumbers to create the six second window. Padding may, in somecircumstances, allow the processing equipment to perform anautocorrelation using fixed template sizes when data availability may belimited. In some embodiments, step 8508 may include the processingequipment performing a cross-correlation of the conditioned window ofdata and another waveform.

In an illustrative example, once the first second of data is obtained,the processing equipment may begin one or more operations of Search Modeor Locked Mode. For example, when one second of data may normally beused as the template for a six second buffer, Fast Start may select onesixth of the buffer size for the template. Accordingly, for the firstsecond the template may be the most recent one sixth of a second ofdata, as shown by panel 8550. As the buffer increases in size, thetemplate may also increase in size. As shown in panel 8552, when twoseconds of data have been buffered, the processing equipment may againselect the most recent one sixth of the buffer (i.e., one third of asecond in this example) as a template and perform the autocorrelation.When sufficient data has been buffered such as, for example, six secondsof data as shown in panel 8554 (with a one second template), theprocessing equipment may leave Fast Start mode and begin normaloperation. The duration for which system 300 is in Fast Start mode maydepend on the true physiological rate, the buffer size, and/or thetemplate size.

Step 8510 may include the processing equipment performing an analysis ofthe autocorrelation of step 8508. In some embodiments, step 8510 mayinclude analyzing more than one autocorrelation, for example,corresponding to one or more buffer and/or template sizes used duringFast Start. Step 8510 may include the processing equipment determining anumber of threshold crossings (e.g., as shown in flow diagram 500 ofFIG. 5), identifying and analyzing a peak shape (e.g., as shown in flowdiagram 900 of FIG. 9), performing a cross-correlation of theautocorrelation with a cross-correlation waveform (e.g., as shown inflow diagram 1800 of FIG. 18), any other suitable analysis of theautocorrelation of step 8508, or any combination thereof. In someembodiments, the output of step 8510 may be an estimate of aphysiological rate, determined using any suitable technique. In someembodiments, the processing equipment may analyze the autocorrelation ofstep 8508 and determine that a different template should be used withthe same buffered window of data. Accordingly, the processing equipmentmay perform step 8508 again using the different template, as shown bythe dashed arrow.

Step 8512 of flow diagram 8500 may include the processing equipmentdetermining one or more algorithm settings based on the analysis of step8510. In some embodiments, the one or more algorithm settings mayinclude one or more initialization parameters. For example, theprocessing equipment may determine a rate estimate, and thus suitableinitialization parameters, based on a number of threshold crossings, apeak shape, a cross-correlation of the autocorrelation of step 8508 witha cross-correlation waveform, any other suitable analysis, or anycombination thereof.

In some embodiments, one or more aspects of an algorithm may also bechanged when system 300 or system 10 is in Fast Start mode, as comparedto the algorithm used during normal operation. For example, if signalconditioning of step 8506 included a curve fit subtraction, Fast Startmay include the processing equipment performing the subtraction over asmaller amount of signal. Accordingly, the curve fitting will likelyremove relatively higher frequencies from the signal, which may bebeneficial because typically only rates of around 120 BPM and higher arelikely to be found when a one second buffer of data is used.

FIG. 86 is a flow diagram 8600 of illustrative steps for implementingSearch Mode and Locked Mode, in accordance with some embodiments of thepresent disclosure.

Step 8602 may include processing equipment identifying one or moreinitialization parameters for processing a received physiologicalsignal. The processing equipment may use any suitable technique such as,for example, those described in the context of Search Mode, to identifyone or more initialization parameters, in accordance with the presentdisclosure. In some embodiments, initialization parameters may includeone or more settings of a band pass filter such as, for example, a highand low frequency cutoff value (e.g., a frequency range), a high or lowcutoff for a respective low-pass filter or high-pass filter, arepresentative frequency value, a set of one or more coefficients, anyother suitable parameters, or any combination thereof. In someembodiments, the initialization parameters may be determined based onthe received physiological signal.

Step 8604 may include the processing equipment determining whether touse one or more initialization parameters (IP) identified at step 8602or a previously calculated rate (CR) to filter an autocorrelation of awindow of data buffered from the physiological signal. In someembodiments, the processing equipment may determine that a previouslycalculated rate, associated with a passed test at step 8614, may be usedto provide filter information (e.g., a period P). In some embodiments,the processing equipment may determine that if the previously calculatedrate is not associated with a passed test at step 8614, the one or moreidentified initialization parameters of step 8602 are to be used toprovide filter information. In some embodiments, the processingequipment may determine that no previously calculated rate is available(e.g., during start-up, or instances of high-noise in the physiologicalsignal), and may select the one or more identified initializationparameters of step 8602 to provide filter information. The determinationof step 8604 may be based on the physiological signal or metric derivedthereof (e.g., a noise metric or a confidence metric)

Step 8606 may include the processing equipment performing anautocorrelation on a window of data buffered from the physiologicalsignal. In some embodiments, the autocorrelation of step 8606 mayinclude correlating a first portion (e.g., a template) of the window ofdata with a second portion of the window of data. The first and secondportions may be exclusive of one another, may share one or more samples,or may be selected by any other suitable partition of the window ofdata. In some embodiments, a stored template may be used to perform theautocorrelation (e.g., as discussed in the context of flow diagram8200). The resulting autocorrelation output of step 8606 may exhibit oneor more peaks. In some embodiments, step 8606 may include the processingequipment, pre-processor 320, or both, performing signal conditioning onthe physiological signal and/or autocorrelation output. Signalconditioning may include filtering (e.g., low pass, high pass, bandpass, notch, or any other suitable filter), amplifying, performing anoperation on the received signal (e.g., taking a derivative, averaging),performing any other suitable signal conditioning, or any combinationthereof. For example, in some embodiments, step 8606 may includeremoving a DC offset, low frequency components, or both, of thephysiological signal. In a further example, step 8606 may includesmoothing the received physiological signal (e.g., using a movingaverage or other smoothing technique). In some embodiments, step 8606may include the processing equipment performing a cross-correlation ofthe window of data, or a portion thereof, and another waveform.

Step 8608 may include the processing equipment filtering theautocorrelation output of step 8606 based on either the IP or CR of step8604. In some embodiments, the processing equipment may apply anadjustable band-pass filter to the autocorrelation output of step 8606.For example, the band-pass filter may be adjusted to center at afrequency selected at step 8604 (e.g., corresponding to either thepreviously calculated rate or the rate associated with the one or moreinitialization parameters). The processing equipment may apply anysuitable type of filter at step 8608, having any suitable spectralcharacteristics (e.g., cut-off, roll-off shape and size, and/orbandwidth).

Step 8610 may include the processing equipment calculating a rate basedon the filtered autocorrelation output of step 8608. The processingequipment may use any suitable technique such as, for example, thosedescribed in the context of Search Mode and/or Locked Mode, to calculatea rate based on an autocorrelation output, in accordance with thepresent disclosure. For example, step 8610 may include generating athreshold using a CFAR window and a binary signal to calculate the rate.

Step 8612 may include the processing equipment performing aQualification for the calculated rate of step 8610. The processingequipment may implement any suitable qualification technique such as,for example, those techniques disclosed in the context of FIGS. 38-57.In some embodiments, for example, step 8612 may include the processingequipment performing a cross-correlation of the window of data bufferedfrom the physiological signal and a cross-correlation template. Thecross-correlation output may be analyzed using any suitablequalification test to qualify or disqualify a calculated rate.

Step 8614 may include the processing equipment determining whether toqualify or disqualify the calculated rate of step 8610. Step 8616 mayinclude the processing equipment posting the rate calculated at step8610 if it has been qualified at step 8614. Step 8616 may includedisplaying the posted rate (e.g., on display 20 of system 10), storingthe rate in suitable memory, replacing a previously posted rate,performing any other suitable processing, or any combination thereof. Ifthe calculated rate of step 8610 is disqualified at step 8614, theprocessing equipment may then repeat step 8602 and/or step 8604. In someembodiments, the calculated rate of step 8610 may be used in a furtheriteration at step 8604, if qualified at step 8614, after the rate hasbeen posted at step 8616.

FIG. 87 is a flow diagram 8700 of illustrative steps for implementingSearch Mode, in accordance with some embodiments of the presentdisclosure.

Step 8702 may include processing equipment receiving at least onephysiological signal from a physiological sensor, memory, any othersuitable source, or any combination thereof. For example, referring tosystem 300 of FIG. 3, the processing equipment may receive aphysiological signal from input signal generator 310. Sensor 318 ofinput signal generator 310 may be coupled to a subject, and may detectphysiological activity such as, for example, RED and/or IR lightattenuation by tissue, using a photodetector. In some embodiments,physiological signals generated by input signal generator 310 may bestored in memory (e.g., any suitable memory of system 10 or system 300)after being pre-processed by pre-processor 320. In such cases, step 8702may include recalling the signals from the memory for furtherprocessing. In some embodiments, step 8702 may include receiving aparticular time interval or corresponding number of samples of thephysiological signal. In some embodiments, step 8702 may includereceiving a digitized, sampled, and pre-processed physiological signal.The physiological signal of step 8702 may include a PPG signal, whichmay include a sequence of pulse waves and may exhibit motion artifacts,noise from ambient light, electronic noise, system noise, any othersuitable signal component, or any combination thereof.

Step 8704 may include the processing equipment determining whether adata storage buffer is filled. In some embodiments, the buffer may bedetermined to be filled when a full window of data of a desired lengthhas been stored (“buffered”). For example, a six second window of datamay be desired, and the processing equipment may wait as more data isbuffered until the full six seconds is stored. In some embodiments, suchas during Fast Start, the processing equipment may determine that thebuffer is sufficiently filled to proceed to step 8706, although whatwould be considered a full window of data has not been buffered. In someembodiments, the buffer may continually store the data from the incomingphysiological signal, and accordingly continually update the contents ofat least a portion of the buffer.

Step 8706 may include the processing equipment performing signalconditioning on the buffered window of data of step 8704. Signalconditioning may include removing DC components, low frequencycomponents, or both, from the window of data (e.g., by high-pass orband-pass filtering). In some embodiments, a varying baseline may beremoved from the window of data (i.e., de-trending) to constrain thedata average to zero. In some embodiments step 8706 may includecalculating an ensemble average window of data of multiple windows ofdata. In some embodiments, step 8706 may include smoothing thephysiological signal. For example, a moving average may be calculatedand outputted as the conditioned signal. In some embodiments, step 8706may include subtracting a quadratic fit and a cubic fit from thephysiological signal to remove the DC and low frequency components.

Step 8708 may include the processing equipment performing anautocorrelation on a window of data buffered from the physiologicalsignal. In some embodiments, the autocorrelation of step 8708 mayinclude correlating a first portion (e.g., a template) of the window ofdata with a second portion of the window of data. The first and secondportions may be exclusive of one another, may share one or more samples,or may be selected by any other suitable partition of the window ofdata. In some embodiments, a stored template may be used to perform theautocorrelation (e.g., as discussed in the context of flow diagram8200). The resulting autocorrelation output of step 8708 may exhibit oneor more peaks.

Step 8710 may include the processing equipment performing across-correlation of the autocorrelation of step 8708 with across-correlation waveform. In some embodiments, step 8710 may includethe processing equipment performing a cross-correlation of theconditioned physiological signal of step 8706 with a cross-correlationwaveform, and step 8708 need not be performed. The following discussion,and FIG. 87, will reference using the autocorrelation of step 8708 forillustration, although the same techniques will apply if step 8708 isomitted. The cross-correlation waveform may include a concatenation ofsegments, each including a waveform of a particular characteristicfrequency. Further detail regarding generation of, use of, andproperties of, the cross-correlation waveform is provided above in thediscussion of FIGS. 18-20, for example. The output of step 8710 may be across-correlation output, exhibiting segments corresponding to thesegments of the cross-correlation waveform.

Step 8712 may include the processing equipment analyzing thecross-correlation output of step 8710 to determine one or more algorithmsettings. In some embodiments, step 8712 may include determining amaximum in the cross-correlation output, and identifying a segment ofthe cross-correlation waveform corresponding to the maximum. In someembodiments, step 8712 may include identifying a pattern in thecross-correlation. In some embodiments, characteristics of an upperenvelope may be calculated, compared with threshold values, or otherwiseanalyzed to identify a physiological peak. In some embodiments, theprocessing equipment may use any of the cross-correlation analysistechniques disclosed in the context of the flow diagrams of FIGS. 18,23, 25, 27, 29, and 33. For example, step 8712 may include theprocessing equipment identifying one or more peaks of thecross-correlation output. The analysis may provide one or more algorithmsettings, such as a representative physiological rate, associatedperiod, or likely ranges thereof.

Step 8714 may include the processing equipment determining whether oneor more cross-correlation tests have been passed based on the analysisof step 8712. In some embodiments, the processing equipment may use anyof the cross-correlation tests disclosed in the context of the flowdiagrams of FIGS. 18, 23, 25, 27, 29, and 33. For example, step 8712 mayinclude the processing equipment qualifying (i.e., passing the test) ordisqualifying (i.e., not passing the test) one or more peaks of thecross-correlation output based on a threshold. For example, the peakheight may be compared to a threshold equal to six times the standarddeviation of the cross-correlation waveform. If the test is not passedat step 8714, the processing equipment may continue on to step 8722 andwait one second before performing one or more of steps 8706-8712 again.If the test is passed at step 8714, the processing equipment maycontinue on to step 8716.

Step 8716 may include the processing equipment performing across-correlation of the buffered window of data with one or morecross-correlation templates (e.g., stored in a reference library). Thecross-correlation may be performed using any suitable algorithm. Theoutput of step 8716 may be a cross-correlation output, which may includea series of cross-correlation values taken for a corresponding series oftime lags (or sample number lags) between the predefined template andthe physiological signal. In some embodiments, any of the disclosedtechniques of flow diagram 3800 of FIG. 38 may be used by the processingequipment at step 8716, in accordance with the present disclosure.

Step 8718 may include the processing equipment analyzing thecross-correlation output(s) of step 8716 to qualify or disqualify theinitialization parameters, a calculated rate, or both. Across-correlation output of step 8716 may include one or more peaks,indicative of high correlation between the physiological signal and apredefined template. In some embodiments, step 8718 may includeanalyzing one or more peaks, segments, or portions thereof, of across-correlation waveform, determining one or more metric values, anyother suitable analysis, or any combination thereof. In someembodiments, step 8718 may include using any of the techniques disclosedin FIGS. 43, 46, 48, and 53-57. For example, tests described above suchas, for example, the Symmetry Test, Radius Test, Angle Test, Area Test,Area Similarity Test, Statistical Property Test, or any other suitabletest, or combination thereof, may be performed at step 8718 to analyzethe one or more cross-correlation output(s) of step 8716. The processingequipment may perform any suitable analysis at step 8718 to qualify ordisqualify initialization parameters, a calculated rate, or both,associated with the one or more cross-correlation outputs.

Step 8720 may include the processing equipment qualifying ordisqualifying initialization parameters, a calculated rate, or both,based on the analysis of step 8718. In some embodiments, qualification(or disqualification) may depend on a comparison between one or metricscomputed at step 8718 and one or more threshold values. In someembodiments, a disqualification at step 8720 may trigger steps 8702-8718to repeat after waiting one second at step 8722. In some embodiments, adisqualification at step 8720 may trigger an analysis different thanthat of flow diagram 8700 to be performed to either qualify ordisqualify the initialization parameters, calculated rate, or both,associated with the cross-correlation output.

Step 8722 may include the processing equipment waiting one second, orany other suitable time period, before repeating any of the steps offlow diagram 8700 after a test fail at step 8714 and/or a ratedisqualification at step 8720. In some embodiments, the wait time mayallow data stored in the buffer to be updated (e.g., partially replacedwith new data). For example, when the processing equipment determinesthat one second has passed since the test fail at step 8714 and/or therate disqualification at step 8720, the processing equipment may thenperform signal conditioning at step 8706 on the new window of data inthe buffer. In a further example, when the processing equipmentdetermines that one second has not yet passed since the test failed atstep 8714 and/or the rate disqualification at step 8720, the processingequipment may proceed to step 8702 and allow further, more recent datato be stored in the buffer until filled (e.g., as determined at step8704).

FIG. 88 is a flow diagram 8800 of illustrative steps for implementingLOCKED MODE, in accordance with some embodiments of the presentdisclosure.

Step 8802 may include processing equipment receiving at least onephysiological signal from a physiological sensor, memory, any othersuitable source, or any combination thereof. For example, referring tosystem 300 of FIG. 3, processor 312 may receive a physiological signalfrom input signal generator 310. Sensor 318 of input signal generator310 may be coupled to a subject, and may detect physiological activitysuch as, for example, RED and/or IR light attenuation by tissue, using aphotodetector. In some embodiments, physiological signals generated byinput signal generator 310 may be stored in memory (e.g., any suitablememory of system 10 or system 300) after being pre-processed bypre-processor 320. In such cases, step 8802 may include recalling thesignals from the memory for further processing. In some embodiments,step 8802 may include receiving a particular time interval orcorresponding number of samples of the physiological signal. In someembodiments, step 8802 may include receiving a digitized, sampled, andpre-processed physiological signal. The physiological signal of step8802 may include a PPG signal, which may include a sequence of pulsewaves and may exhibit motion artifacts, noise from ambient light,electronic noise, system noise, any other suitable signal component, orany combination thereof.

Step 8804 may include the processing equipment determining whether adata storage buffer is filled. In some embodiments, the buffer may bedetermined to be filled when a full window of data of a desired lengthhas been buffered. For example, a six second window of data may bedesired, and the processing equipment may wait as more data is buffereduntil the full six seconds is stored. In some embodiments, such asduring Fast Start, the processing equipment may determine that thebuffer is sufficiently filled to proceed to step 8806, although whatwould be considered a full window of data has not been buffered. In someembodiments, the buffer may continually store the data from the incomingphysiological signal, and accordingly continually update the contents ofat least a portion of the buffer.

Step 8806 may include the processing equipment performing signalconditioning on the buffered window of data of step 8804. Signalconditioning may include removing DC components, low frequencycomponents, or both, from the window of data (e.g., by high-pass orband-pass filtering). In some embodiments, a varying baseline may beremoved from the window of data (i.e., de-trending) to constrain thedata average to zero. In some embodiments step 8806 may includecalculating an ensemble average window of data of multiple windows ofdata. In some embodiments, step 8806 may include smoothing thephysiological signal. For example, a moving average may be calculatedand outputted as the conditioned signal. In some embodiments, 8806 mayinclude subtracting a quadratic fit and a cubic fit from thephysiological signal to remove the DC and low frequency components.

Step 8808 may include the processing equipment performing anautocorrelation on a window of data buffered from the physiologicalsignal. In some embodiments, the autocorrelation of step 8808 mayinclude correlating a first portion (e.g., a one second template) of thewindow of data with a second portion of the window of data. The firstand second portions may be exclusive of one another, may share one ormore samples, or may be selected by any other suitable partition of thewindow of data. In some embodiments, a stored template may be used toperform the autocorrelation (e.g., as discussed in the context of flowdiagram 8200). The resulting autocorrelation output of step 8808 mayexhibit one or more peaks. In some embodiments, step 8808 may includethe processing equipment performing a cross-correlation of the window ofdata, or a portion thereof, and another waveform.

Step 8810 may include the processing equipment applying a band-passfilter to the autocorrelation output of step 8808. In some embodiments,coefficients of the band-pass filter may be fixed or adjustable. Forexample, the high and low cutoff frequencies of the band-pass filter maydepend on one or more initialization parameters and/or calculated rates.In a further example, the band-pass filter may be adjusted to center ata frequency determined at step 8846 (e.g., corresponding to either thepreviously calculated rate or the rate associated with the one or moreinitialization parameters). The processing equipment may apply anysuitable type of filter at step 8810, having any suitable spectralcharacteristics (e.g., cut-off, roll-off shape and size, and/orbandwidth).

Step 8812 may include the processing equipment performing CFAR analysison the filtered autocorrelation output of step 8810. In someembodiments, the processing equipment may use any of the techniquesdisclosed in the context of FIG. 72 and FIG. 75. For example, step 8812may include the processing equipment generating one or more thresholdsusing a CFAR window, and then optionally generating a binary signalbased on crossings of the filtered autocorrelation of step 8810 and thethreshold.

Step 8814 may include the processing equipment determining whether thecurrent processing is the first instance. For example, the first timethat step 8814 is performed, the processing equipment may determine“YES” at step 8814. In some embodiments, when it is the first time, asubsequently calculated rate need not be posted but rather used todetermine one or more algorithm settings for the next iteration of flowdiagram 8800 (e.g., see steps 8838-8846). In some embodiments, becausethe first rate is calculated based on initialization parameters, thefirst rate may not necessarily be as accurate as subsequently calculatedrates that are based on previously calculated rates from Locked Mode. Ifthe processing equipment determines that the current processing is notthe first instance, then the processing equipment may proceed to step8816.

Step 8816 may include the processing equipment determining whether thereare two transitions in the binary signal generated at step 8812. Forexample, the presence of two or more transitions may indicate suitablecrossings of the autocorrelation output and the threshold, andaccordingly a rate may be calculated. If the processing equipmentdetermines that the binary signal does not exhibit two transitions, thenthe processing equipment may proceed to perform failure handling at step8828. Following failure handling step 8828, the processing equipment maycontinue to use and/or post the previously posted rate at step 8830. Ifthe processing equipment determines that the binary signal does exhibittwo or more transitions, then the processing equipment may proceed tocalculate a rate at step 8818. Step 8818 may include the processingequipment performing any suitable rate calculation technique such asthose disclosed in the context of FIG. 72. For example, the processingequipment may determine the period between successive peaks in thebinary signal, and determine a rate corresponding to the period.

Step 8820 may include the processing equipment determining whether thedifference between the rate calculated at step 8818 and the previouslyposted rate is greater than a difference threshold. In some embodiments,step 8820 may be used to prevent relatively large changes in the postedrate that are unlikely to correspond to an increase in the physiologicalrate. For example, a difference threshold of 24 BPM may be used at step8820. In this illustrative example, a calculated rate of more than 24BPM higher than the posted rate, or less than 24 BPM lower than theposted rate, may be limited to the previously posted rate plus or minusthe 24 BPM, respectively. A calculated rate within a plus or minus 24BPM range of the posted rate would be passed on to step 8832. If therate difference is larger than the difference threshold, the processingequipment may perform failure handling at step 8822.

Step 8832 may include the processing equipment performing across-correlation of the buffered window of data with one or morecross-correlation templates (e.g., stored in a reference library). Thecross-correlation may be performed using any suitable algorithm. Theoutput of step 8832 may be a cross-correlation output, which may includea series of cross-correlation values taken for a corresponding series oftime lags (or sample number lags) between the predefined template andthe physiological signal. In some embodiments, any of the disclosedtechniques of flow diagram 3800 of FIG. 38 may be used by the processingequipment at step 8832, in accordance with the present disclosure.

Step 8834 may include the processing equipment qualifying ordisqualifying a calculated rate based on an analysis of thecross-correlation output of step 8832. A cross-correlation output ofstep 8832 may include one or more peaks, indicative of high correlationbetween the physiological signal and a predefined template. In someembodiments, step 8834 may include analyzing one or more peaks,segments, or portions thereof, of a cross-correlation waveform,determining one or more metric values, any other suitable analysis, orany combination thereof. In some embodiments, step 8834 may includeusing any of the techniques disclosed in FIGS. 43, 46, 48, and 54-57.For example, tests described above such as the Symmetry Test, RadiusTest, Angle Test, Area Test, Area Similarity Test, Statistical PropertyTest, any other suitable test, or any combination thereof, may beperformed at step 8834 to analyze the one or more cross-correlationoutput(s) of step 8832. The processing equipment may perform anysuitable analysis at step 8834 to qualify or disqualify a calculatedrate. In some embodiments, qualification (or disqualification) maydepend on a comparison between one or more metrics and one or morethreshold values. In some embodiments, a disqualification at step 8834may trigger the processing equipment to perform failure handling at step8828.

Following a qualification at step 8834, the processing equipment mayreset a failure counter at step 8836. In some embodiments, the failurecounter may store an index of the failure instances from step 8828and/or step 8822. Step 8836 may include the processing equipmentresetting the failure counter to zero.

Step 8824 may include the processing equipment filtering the calculatedrate of step 8818. In some embodiments, the processing equipment mayapply a filter to smooth, average, or otherwise limit the change of arate to be posted at step 8826. For example, the processing equipmentmay apply an infinite impulse response filter (IIR) to the calculatedrate. The filter may be a fixed or adjustable weight filter. Forexample, the filter weights may be adjusted based on signal confidence(e.g., based on an independent signal confidence metric, based onqualification metric values, based on CFAR analysis).

Step 8826 may include the processing equipment posting the filtered rateof step 8824 and/or the previous rate of step 8830. Step 8826 mayinclude displaying the posted rate (e.g., on display 20 of system 10),storing the rate in suitable memory, replacing a previously posted rate,performing any other suitable processing, or any combination thereof.

Failure handling steps 8828 and 8822 may include incrementallyincreasing a counter to keep track of the number of failures. In someembodiments, failure handling step 8828 and/or failure handling step8822 may include the processing equipment returning to Search Mode aftera particular number of failures is reached.

If at step 8814 the processing equipment determines that the currentprocessing is not the first instance, then the processing equipment mayproceed to step 8838 and determine whether the binary signal of step8812 exhibits two or more transitions. If at step 8838 the processingequipment determines that the binary signal of step 8812 does notexhibit two or more transitions, the processing equipment may proceed tooperate in Search Mode at step 8840 to determine one or more newinitialization parameters.

Step 8842 may include the processing equipment performing any suitablerate calculation technique such as those disclosed in the context ofFIG. 72. For example, the processing equipment may determine the periodbetween successive peaks in the binary signal, and determine a ratecorresponding to the period.

Step 8844 may include the processing equipment waiting a suitable timeperiod, before repeating any of the steps of flow diagram 8800 aftercalculating a rate at step 8842 and/or posting a rate at step 8826. Insome embodiments, the wait time may allow data stored in the buffer tobe updated (e.g., partially replaced with new data). For example, whenthe processing equipment determines that a wait time of one second haspassed since the rate calculation of step 8842 and/or rate posting ofstep 8826, the processing equipment may then receive the most recent onesecond of data of the physiological signal at step 8802.

Step 8846 may include the processing equipment determining one or morealgorithm settings based on a previously calculated rate, a posted rate,one or more initialization parameters, any other suitable information,or any combination thereof. Algorithm settings may include, for example,signal conditioning settings (e.g., de-trending parameters and curve fittype), autocorrelation settings (e.g., template size and or buffersize), filter settings (e.g., coefficients of a band-pass filter), CFARsettings (e.g., window size, guard size, and/or coefficients), any othersuitable settings, or any combination thereof. The processing equipmentmay reset or adjust one or more algorithm settings based on a calculatedrate.

It will be understood that flow diagrams 8700 and 8800 of FIGS. 87 and88, respectively, are merely illustrative and various modifications canbe made that are within the scope of the present disclosure. Forexample, the CFAR analysis at step 8812 need not generate a binarysignal. Instead, the locations of the threshold crossings can beidentified and used in the remaining steps of FIG. 88.

The foregoing is merely illustrative of the principles of thisdisclosure and various modifications may be made by those skilled in theart without departing from the scope of this disclosure. The abovedescribed embodiments are presented for purposes of illustration and notof limitation. The present disclosure also can take many forms otherthan those explicitly described herein. Accordingly, it is emphasizedthat this disclosure is not limited to the explicitly disclosed methods,systems, and apparatuses, but is intended to include variations to andmodifications thereof which are within the spirit of the followingclaims.

What is claimed is:
 1. A subject monitoring system for determiningphysiological information of a subject, comprising: a sensor configuredto generate an intensity signal, wherein the sensor detects lightattenuated by the subject; and processing equipment coupled to thesensor, wherein the processing equipment is configured to: determine avalue indicative of a physiological rate of the subject; determine afirst metric based on the intensity signal; perform a filteringcalculation based on the intensity signal to generate a filteredintensity signal; determine a second metric based on the filteredintensity signal; and determine whether to qualify the value indicativeof the physiological rate of the subject based on the first and secondmetrics.
 2. The system of claim 1, wherein the processing equipment isfurther configured to perform a high-pass filtering calculation with acut-off at a frequency corresponding to approximately double the valueindicative of the physiological rate.
 3. The system of claim 1, whereinthe first metric comprises one of a standard deviation, root-mean-squaredeviation, an amplitude, a sum, and an integral.
 4. The system of claim1, wherein the second metric comprises one of a standard deviation,root-mean-square deviation, an amplitude, a sum, and an integral.
 5. Thesystem of claim 1, wherein the processing equipment is furtherconfigured to compare the first metric to the second metric.
 6. Thesystem of claim 1, wherein the processing equipment is furtherconfigured to: determine a ratio of the first metric to the secondmetric; compare the ratio to a threshold; and determine whether toqualify the value of indicative of the physiological rate based on thecomparison of the ratio to the threshold.
 7. The system of claim 1,wherein the intensity signal is a photoplethysmograph signal and whereinthe physiological rate is a pulse rate.
 8. A processing module fordetermining physiological information of a subject, wherein theprocessing module is configured to: receive an intensity signal from adetector, wherein the detector detects light attenuated by the subject;determine a value indicative of a physiological rate of the subject;determine a first metric based on the intensity signal; perform afiltering calculation based on the intensity signal to generate afiltered intensity signal; determine a second metric based on thefiltered intensity signal; and determine whether to qualify the valueindicative of the physiological rate of the subject based on the firstand second metrics.
 9. The processing module of claim 8, furtherconfigured to perform a high-pass filtering calculation with a cut-offat a frequency corresponding to approximately double the valueindicative of the physiological rate.
 10. The processing module of claim8, wherein the first metric comprises one of a standard deviation,root-mean-square deviation, an amplitude, a sum, and an integral. 11.The processing module of claim 8, wherein the second metric comprisesone of a standard deviation, root-mean-square deviation, an amplitude, asum, and an integral.
 12. The processing module of claim 8, furtherconfigured to compare the first metric to the second metric.
 13. Theprocessing module of claim 8, further configured to: determine a ratioof the first metric to the second metric; compare the ratio to athreshold; and determine whether to qualify the value of indicative ofthe physiological rate based on the comparison of the ratio to thethreshold.
 14. The processing module of claim 8, wherein the intensitysignal is a photoplethysmograph signal and wherein the physiologicalrate is a pulse rate.
 15. A method for processing physiologicalinformation of a subject, comprising: receiving an intensity signal froma detector, which detects light attenuated by the subject; determining avalue indicative of a physiological rate of the subject; determining afirst metric based on the intensity signal; performing a filteringcalculation based on the intensity signal to generate a filteredintensity signal; determining a second metric based on the filteredintensity signal; and determining, using processing equipment, whetherto qualify the value indicative of the physiological rate of the subjectbased on the first and second metrics.
 16. The method of claim 15,wherein the filtering calculation comprises a high-pass filteringcalculation with a cut-off at a frequency corresponding to approximatelydouble the value indicative of the physiological rate.
 17. The method ofclaim 15, wherein determining the first metric comprises determining oneof a standard deviation, root-mean-square deviation, an amplitude, asum, and an integral.
 18. The method of claim 15, wherein determiningthe second metric comprises determining one of a standard deviation,root-mean-square deviation, an amplitude, a sum, and an integral. 19.The method of claim 15, further comprising comparing the first metric tothe second metric.
 20. The method of claim 15, further comprising:determining a ratio of the first metric to the second metric; andcomparing the ratio to a threshold, wherein determining whether toqualify the value indicative of the physiological rate comprisesdetermining whether to qualify the value of indicative of thephysiological rate based on the comparison of the ratio to thethreshold.
 21. The method of claim 15, wherein the intensity signal is aphotoplethysmograph signal and wherein the physiological rate is a pulserate.
 22. A computer-readable medium for use in determiningphysiological information of a subject, the computer-readable mediumhaving computer program instructions recorded thereon for: receiving anintensity signal from a detector, which detects light attenuated by thesubject; determining a value indicative of a physiological rate of thesubject; determining a first metric based on the intensity signal;performing a filtering calculation based on the intensity signal togenerate a filtered intensity signal; determining a second metric basedon the filtered intensity signal; and determining whether to qualify thevalue indicative of the physiological rate of the subject based on thefirst and second metrics.
 23. The computer-readable medium of claim 22,wherein the filtering calculation comprises a high-pass filteringcalculation with a cut-off at a frequency corresponding to approximatelydouble the value indicative of the physiological rate.
 24. Thecomputer-readable medium of claim 22, wherein the first metric comprisesone of a standard deviation, root-mean-square deviation, an amplitude, asum, and an integral.
 25. The computer-readable medium of claim 22,wherein the second metric comprises one of a standard deviation,root-mean-square deviation, an amplitude, a sum, and an integral. 26.The computer-readable medium of claim 22, having computer programinstructions recorded thereon for comparing the first metric to thesecond metric.
 27. The computer-readable medium of claim 22, havingcomputer program instructions recorded thereon for: determining a ratioof the first metric to the second metric; and comparing the ratio to athreshold, wherein determining whether to qualify the value indicativeof the physiological rate comprises determining whether to qualify thevalue of indicative of the physiological rate based on the comparison ofthe ratio to the threshold.
 28. The computer-readable medium of claim22, wherein the intensity signal is a photoplethysmograph signal andwherein the physiological rate is a pulse rate.